510(k) · Cleared
Recalled · 2009Scimed 5 French Impulse Angiographic Catheters
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Scimed Life Systems, Inc. · DQO Catheter, Intravascular, Diagnostic
Cleared on Feb 10, 1997 after a 68-day review. The FDA summary names its predicate without a number. 1 of the 3 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it. It has been recalled 3 times.
- Decided
- Feb 10, 1997
- Review
- 68 days
- Class
- Class II
- Product code
- DQO
- Recalls
- 3
- Predicates
- 0
2 later devices descend from it, 1 citing it directly. 1 of the 3 devices in this family, counting this one, has a Class I recall.
- This deviceK964859 Scimed 5 French Impulse Angiographic CathetersScimed Life Systems, Inc. · 1997
- Descendant · cites it directly · 1 of its ownK120495 Impulse and Expo Angiographic CatheterBoston Scientific Corp · 2012
- Descendant · 2 generations on · 0 of its ownK152605 Impulse Angiographic Catheter, Expo Angiographic CatheterBoston Scientific Corporation · 2015 · Recalled (Class I)
Class I recalls in this family
- K152605 Impulse Angiographic Catheter, Expo Angiographic…2 generations on · 2015
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K964859 | Scimed 5 French Impulse Angiographic Catheters | Scimed Life Systems, Inc. | 1997 | — |
| +1 | K120495 | Impulse and Expo Angiographic Catheter | Boston Scientific Corp | 2012 | — |
| +2 | K152605 | Impulse Angiographic Catheter, Expo Angiographic Catheter | Boston Scientific Corporation | 2015 | Class I |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2015 | 1 | 1 |
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? (2)
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 |
|---|---|---|---|
| * | — | SCIMED® 5 French EXPO™ Angiographic Catheter Named without a submission number | |
| * | — | Cordis® Corporation 5 F Infiniti™ Angiographic Catheter Named without a submission number |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120495 | Impulse and Expo Angiographic Catheter | 2012 | 1 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 5, 2009 | Not classified | Z-2014-2009 | Packaging | Boston Scientific is initiating a recall removal of numerous batches/lots of Wiseguide Guide Catheter, Impulse Angiographic (Diagnostic) Catheter, Expo Angiographic (Diagnostic) Catheter. Boston Scientific has determined that the sterile… |
| Nov 20, 2007 | Not classified | Z-0935-2008 | Release of Material/Component prior to receiving test results | Flash may be protruding from the lumen of the catheter shaft. If this flash is present in the catheter, there is the potential of an embolization resulting from the flash detaching from the device during the procedure. |
| Jun 4, 2007 | Not classified | Z-1159-2007 | Process control | Labels on the carton from two batches/lots of Impulse Angiographic Catheters may indicate a different curve style than the device that is actually in the carton. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K152605Impulse Angiographic Catheter, Expo Angiographic CatheterBoston Scientific Corporation · 2015 · 2 generations on · ◆ in the 2015 descendants bar of FIG. 148 Class I recalls
What does this lineage say?
- Of its descendants, K120495 (Boston Scientific Corp, 2012) has gone furthest, with 1 descendant of its own.
How does its category compare?
All DQO devicesDQO Catheter, Intravascular, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DQO
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQO
148in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQO
1in 2023
Class I (11 since 2007) Class II/III not classified
Adverse event reports per year · DQO
656in 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 SCIMED IMPULSE 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/K964859 · printed Nov 6, 2026
Cite this page
510(k) Report. “K964859: Scimed 5 French Impulse Angiographic Catheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K964859
Report an extraction error
Are you the manufacturer?
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