510(k) · Cleared
Recalled · 2012Imager II Angiographic Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific/Medi-Tech · DQO Catheter, Intravascular, Diagnostic
Cleared on Sep 7, 2001 after a 100-day review. The FDA summary names its predicate without a number. 2 of the 7 devices in its family, counting itself, have a Class I recall. 6 later devices descend from it. It has been recalled 2 times.
- Decided
- Sep 7, 2001
- Review
- 100 days
- Class
- Class II
- Product code
- DQO
- Recalls
- 2
- Predicates
- 0
6 later devices descend from it, 3 citing it directly. 2 of the 7 devices in this family, counting this one, have a Class I recall.
- This deviceK011664 Imager II Angiographic CatheterBoston Scientific/Medi-Tech · 2001
- Descendant · cites it directly · 2 of its ownK121694 Imager II Angiographic CatheterBoston Scientific Corp · 2012 · Recalled (Class I)
- Descendant · cites it directly · 2 of its ownK022621 Boston Scientific Imager II 4F Selective Angiographic CatheterBoston Scientific Corp · 2002 · Recalled
- Descendant · 2 generations on · 1 of its ownK133130 Beacon Tip Torcon NB Advantage Catheter, Torcon NB Advantage CatheterCook, Inc. · 2015 · Recalled (Class I)
- Descendant · cites it directly · 1 of its ownK050863 Imager II Angiographic CatheterBoston Scientific Corp · 2005 · Recalled
- Descendant · 3 generations on · 0 of its ownK161822 Torcon NB Advantage CathetersCook Incorporated · 2016
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 6 · See all- K121694Imager II Angiographic CatheterBoston Scientific Corp · 2012 · cites it directly2descendants
- K022621Boston Scientific Imager II 4F Selective Angiographic CatheterBoston Scientific Corp · 2002 · cites it directly2descendants
- K133130Beacon Tip Torcon NB Advantage Catheter, Torcon NB Advantage CatheterCook, Inc. · 2015 · 2 generations on1descendant
- K050863Imager II Angiographic CatheterBoston Scientific Corp · 2005 · cites it directly1descendant
- K161822Torcon NB Advantage CathetersCook Incorporated · 2016 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K011664 | Imager II Angiographic Catheter | Boston Scientific/Medi-Tech | 2001 | — |
| +1 | K121694 | Imager II Angiographic Catheter | Boston Scientific Corp | 2012 | Class I |
| +1 | K022621 | Boston Scientific Imager II 4F Selective Angiographic Catheter | Boston Scientific Corp | 2002 | 1 |
| +2 | K133130 | Beacon Tip Torcon NB Advantage Catheter, Torcon NB Advantage Catheter | Cook, Inc. | 2015 | Class I |
| +1 | K050863 | Imager II Angiographic Catheter | Boston Scientific Corp | 2005 | 3 |
| +3 | K161822 | Torcon NB Advantage Catheters | Cook Incorporated | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2012 | 2 | 1 |
| 2015 | 1 | 1 |
| 2016 | 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.
2 devices in this family have 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 |
|---|---|---|---|
| * | — | NightHawk Angiographic Catheter Named without a submission number |
What descends from it? (6)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 15, 2012 | Not classified | Z-1394-2012 | Package design/selection | Boston Scientific Corporation is initiating a Medical Device Recall of certain lots/batches of the Imager" II Catheter (Urology) and the Imager" II Angiographic Catheter . An investigation has found that, during shipping, some units in… |
| Oct 12, 2007 | Not classified | Z-0279-2008 | Packaging | Mislabeled: Units within the identified lot/batch were incorrectly labeled as 5F on the outer carton and pouch when the product was actually a 4F device. |
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.
- K121694Imager II Angiographic CatheterBoston Scientific Corp · 2012 · Cites it directly · ◆ in the 2012 descendants bar of FIG. 12 Class I recalls
- K133130Beacon Tip Torcon NB Advantage Catheter, Torcon NB Advantage CatheterCook, Inc. · 2015 · 2 generations on · ◆ in the 2015 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K121694 (Boston Scientific Corp, 2012) has gone furthest, with 2 descendants 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 IMAGER™II Angiographic Catheters are indicated for use to provide a pathway for delivering contrast media to selected sites in the vascular system.
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/K011664 · printed Nov 4, 2026
Cite this page
510(k) Report. “K011664: Imager II Angiographic Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K011664
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026