510(k) · Cleared
Recalled · Class I · 2024Impulse Angiographic Catheter, Expo Angiographic Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corporation · DQO Catheter, Intravascular, Diagnostic
Cleared on Oct 29, 2015 as substantially equivalent to K120495 (Boston Scientific Corp, 2012) after a 48-day review. Its family tree reaches back 2 generations to 1994. 1 of the 6 devices in its family, counting itself, has a Class I recall. It has been recalled 48 times, including 48 Class I recalls.
- Decided
- Oct 29, 2015
- Review
- 48 days
- Class
- Class II
- Product code
- DQO
- Recalls
- 48 (48 Class I)
- Predicates
- 1
Its longest line of descent runs back 2 generations to K934581 (1994). 5 ancestors in all. No later device cites it as a predicate yet. 1 of the 6 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK934581 Scimed 5, 7, and 8 French Angiographic CathetersScimed Life Systems, Inc. · 1994 · Recalled
- 1 generation backK120495 Impulse and Expo Angiographic CatheterBoston Scientific Corp · 2012
- This deviceK152605 Impulse Angiographic Catheter, Expo Angiographic CatheterBoston Scientific Corporation · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K934581 | Scimed 5, 7, and 8 French Angiographic Catheters | Scimed Life Systems, Inc. | 1994 | 1 |
| −1 | K120495 | Impulse and Expo Angiographic Catheter | Boston Scientific Corp | 2012 | — |
| 0 (this device) | K152605 | Impulse Angiographic Catheter, Expo Angiographic Catheter | Boston Scientific Corporation | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DQO device
- #1 K254278 Arterial Pressure Monitoring Set/Trayscore 14.4 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K120495 | Impulse and Expo Angiographic CatheterSummary page 4…e™ and Expo™ Angiographic Catheter Common Name: Diagnostic Intravascular Guide Catheter Classification: Il Product Code: DQO, 21 CFR 870.1200 Predicate Device: Impulse: K120495 (21 May 2012) Expo: K120495 (21 May 2012) Device Description: The Impulse™ and Expo™ Angiographic Catheters are single lumen ca… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 21, 2024 | Class I | Z-1666-2024 | Under Investigation by firm | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the… |
| Mar 21, 2024 | Class I | Z-1645-2024 | Under Investigation by firm | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the… |
| Mar 21, 2024 | Class I | Z-1657-2024 | Under Investigation by firm | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the… |
| Mar 21, 2024 | Class I | Z-1670-2024 | Under Investigation by firm | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the… |
| Mar 21, 2024 | Class I | Z-1669-2024 | Under Investigation by firm | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the… |
| Mar 21, 2024 | Class I | Z-1673-2024 | Under Investigation by firm | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the… |
| Mar 21, 2024 | Class I | Z-1667-2024 | Under Investigation by firm | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the… |
| Mar 21, 2024 | Class I | Z-1678-2024 | Under Investigation by firm | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the… |
| Mar 21, 2024 | Class I | Z-1640-2024 | Under Investigation by firm | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the… |
| Mar 21, 2024 | Class I | Z-1664-2024 | Under Investigation by firm | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the… |
| Mar 21, 2024 | Class I | Z-1665-2024 | Under Investigation by firm | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the… |
| Mar 21, 2024 | Class I | Z-1651-2024 | Under Investigation by firm | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the… |
| Mar 21, 2024 | Class I | Z-1677-2024 | Under Investigation by firm | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the… |
| Mar 21, 2024 | Class I | Z-1684-2024 | Under Investigation by firm | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the… |
| Mar 21, 2024 | Class I | Z-1644-2024 | Under Investigation by firm | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the… |
| Mar 21, 2024 | Class I | Z-1648-2024 | Under Investigation by firm | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the… |
| Mar 21, 2024 | Class I | Z-1655-2024 | Under Investigation by firm | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the… |
| Mar 21, 2024 | Class I | Z-1683-2024 | Under Investigation by firm | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the… |
| Mar 21, 2024 | Class I | Z-1661-2024 | Under Investigation by firm | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the… |
| Mar 21, 2024 | Class I | Z-1641-2024 | Under Investigation by firm | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the… |
| Mar 21, 2024 | Class I | Z-1650-2024 | Under Investigation by firm | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the… |
| Mar 21, 2024 | Class I | Z-1639-2024 | Under Investigation by firm | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the… |
| Mar 21, 2024 | Class I | Z-1680-2024 | Under Investigation by firm | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the… |
| Mar 21, 2024 | Class I | Z-1658-2024 | Under Investigation by firm | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the… |
| Mar 21, 2024 | Class I | Z-1643-2024 | Under Investigation by firm | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the… |
| Mar 21, 2024 | Class I | Z-1663-2024 | Under Investigation by firm | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the… |
| Mar 21, 2024 | Class I | Z-1672-2024 | Under Investigation by firm | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the… |
| Mar 21, 2024 | Class I | Z-1679-2024 | Under Investigation by firm | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the… |
| Mar 21, 2024 | Class I | Z-1675-2024 | Under Investigation by firm | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the… |
| Mar 21, 2024 | Class I | Z-1671-2024 | Under Investigation by firm | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the… |
| Mar 21, 2024 | Class I | Z-1646-2024 | Under Investigation by firm | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the… |
| Mar 21, 2024 | Class I | Z-1638-2024 | Under Investigation by firm | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the… |
| Mar 21, 2024 | Class I | Z-1652-2024 | Under Investigation by firm | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the… |
| Mar 21, 2024 | Class I | Z-1676-2024 | Under Investigation by firm | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the… |
| Mar 21, 2024 | Class I | Z-1682-2024 | Under Investigation by firm | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the… |
| Mar 21, 2024 | Class I | Z-1662-2024 | Under Investigation by firm | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the… |
| Mar 21, 2024 | Class I | Z-1653-2024 | Under Investigation by firm | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the… |
| Mar 21, 2024 | Class I | Z-1685-2024 | Under Investigation by firm | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the… |
| Mar 21, 2024 | Class I | Z-1656-2024 | Under Investigation by firm | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the… |
| Mar 21, 2024 | Class I | Z-1674-2024 | Under Investigation by firm | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the… |
| Mar 21, 2024 | Class I | Z-1642-2024 | Under Investigation by firm | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the… |
| Mar 21, 2024 | Class I | Z-1649-2024 | Under Investigation by firm | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the… |
| Mar 21, 2024 | Class I | Z-1654-2024 | Under Investigation by firm | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the… |
| Mar 21, 2024 | Class I | Z-1681-2024 | Under Investigation by firm | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the… |
| Mar 21, 2024 | Class I | Z-1668-2024 | Under Investigation by firm | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the… |
| Mar 21, 2024 | Class I | Z-1660-2024 | Under Investigation by firm | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the… |
| Mar 21, 2024 | Class I | Z-1647-2024 | Under Investigation by firm | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the… |
| Mar 21, 2024 | Class I | Z-1659-2024 | Under Investigation by firm | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the… |
The 5 latest of 48 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 3 companies; a new generation was cleared every 18.1 years on median.
- 4 of the 5 ancestors have a recall of any class.
How does its category compare?
All DQO devicesDQO Catheter, Intravascular, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · DQO
2in 2025
2007high 15 (2012) · low 1 (2021)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · DQO
148in 2024
2007high 234 (2018) · low 30 (2020)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQO
1in 2023
2007high 71 (2019) · low 0 (2014)2026
Class I (11 since 2007) Class II/III not classified
Adverse event reports per year · DQO
656in 2025
2007high 933 (2009) · low 312 (2020)2025
MAUDE reports naming product code DQO, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 8 | 106 | 14 | 564 |
| 2008 | 3 | 80 | 4 | 726 |
| 2009 | 8 | 58 | 7 | 933 |
| 2010 | 7 | 137 | 11 | 556 |
| 2011 | 6 | 74 | 7 | 625 |
| 2012 | 15 | 94 | 2 | 532 |
| 2013 | 2 | — | 1 | 753 |
| 2014 | 3 | 109 | 0 | 601 |
| 2015 | 10 | 209 | 1 (1) | 628 |
| 2016 | 4 | 89 | 2 (1) | 614 |
| 2017 | 10 | 176 | 1 | 873 |
| 2018 | 10 | 234 | 2 | 777 |
| 2019 | 6 | 113 | 71 | 386 |
| 2020 | 3 | 30 | 4 (4) | 312 |
| 2021 | 1 | — | 0 | 338 |
| 2022 | 4 | 181 | 1 | 379 |
| 2023 | 4 | 73 | 1 (1) | 391 |
| 2024 | 4 | 148 | 0 | 511 |
| 2025 | 2 | — | 0 | 656 |
| 2026 | 3 | 85 | 24 (4) | — |
What is it indicated for?
The Impulse™ and Expo™ Angiographic Catheters are designed to
provide a pathway to be used for delivering contrast media to selected sites
in the vascular system during an angiographic procedure.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K152605 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152605: Impulse Angiographic Catheter, Expo Angiographic Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152605
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026