510(k) · Cleared
Recalled · 20061-4F Infiniti Angiographic Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cordis Corp. · DQO Catheter, Intravascular, Diagnostic
Cleared on Apr 2, 1996 as substantially equivalent to K930479 (Cordis Corp., 1993) and 1 other predicate after a 22-day review. Its family tree reaches back 1 generation to 1992. 1 of the 44 devices in its family, counting itself, has a Class I recall. 41 later devices descend from it. It has been recalled once.
- Decided
- Apr 2, 1996
- Review
- 22 days
- Class
- Class II
- Product code
- DQO
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K921310 (1992). 2 ancestors in all. 41 later devices descend from it, 5 citing it directly. 1 of the 44 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK921310 Cordis 6 French Paragon Angiographic CatheterCordis Corp. · 1992
- This deviceK960975 1-4F Infiniti Angiographic CatheterCordis Corp. · 1996
- Descendant · cites it directly · 32 of its ownK992051 Radifocus OptitorqueTerumo Medical Corp. · 1999
- Descendant · 2 generations on · 18 of its ownK082561 Spectranetics Quick-Cross Extreme Support CathetersSpectranetics Corp. · 2008
- Descendant · 3 generations on · 13 of its ownK092396 Spectranetics Quick Cross Extreme Support CathetersSpectranetics Corp. · 2009
- Descendant · 2 generations on · 9 of its ownK082736 Radifocus Optitorque Angiographic CatheterTerumo Medical Corp. · 2008
- Descendant · cites it directly · 7 of its ownK970854 5 FR and 6 FR Infiniti Angiographic CatheterCordis Corp. · 1997 · Recalled (Class I)
Showing 5 of 41 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K970854 5 FR and 6 FR Infiniti Angiographic Cathetercites it directly · 1997
Most influential descendants
Showing 5 of 41 · See all- K992051Radifocus OptitorqueTerumo Medical Corp. · 1999 · cites it directly32descendants
- K082561Spectranetics Quick-Cross Extreme Support CathetersSpectranetics Corp. · 2008 · 2 generations on18descendants
- K092396Spectranetics Quick Cross Extreme Support CathetersSpectranetics Corp. · 2009 · 3 generations on13descendants
- K082736Radifocus Optitorque Angiographic CatheterTerumo Medical Corp. · 2008 · 2 generations on9descendants
- K9708545 FR and 6 FR Infiniti Angiographic CatheterCordis Corp. · 1997 · cites it directly7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K921310 | Cordis 6 French Paragon Angiographic Catheter | Cordis Corp. | 1992 | — |
| 0 (this device) | K960975 | 1-4F Infiniti Angiographic Catheter | Cordis Corp. | 1996 | — |
| +1 | K992051 | Radifocus Optitorque | Terumo Medical Corp. | 1999 | — |
| +2 | K082561 | Spectranetics Quick-Cross Extreme Support Catheters | Spectranetics Corp. | 2008 | — |
| +3 | K092396 | Spectranetics Quick Cross Extreme Support Catheters | Spectranetics Corp. | 2009 | — |
| +2 | K082736 | Radifocus Optitorque Angiographic Catheter | Terumo Medical Corp. | 2008 | — |
| +1 | K970854 | 5 FR and 6 FR Infiniti Angiographic Catheter | Cordis Corp. | 1997 | Class I |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 1 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 4 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 4 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K930479 | Nylex CathetersSummary page 1…theter and Percutaneous Catheter Proprietary Name: Cordis 4F Infiniti™ Angiographic Catheter Name of Predicate Devices Cordis Corporation 4F Nylex Angiographic Catheter (K930479) Cordis Corporation Paragon Angiographic Catheter (K9213 10/A) Classification Class II Performance Standards Performance standar… | 1993 |
| * | K921310 | Cordis 6 French Paragon Angiographic CatheterSummary page 1…F Infiniti™ Angiographic Catheter Name of Predicate Devices Cordis Corporation 4F Nylex Angiographic Catheter (K930479) Cordis Corporation Paragon Angiographic Catheter (K9213 10/A) Classification Class II Performance Standards Performance standards have not been established by the FDA under section 514 of… | 1992 |
What descends from it? (41)
See all 415 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K992051 | Radifocus Optitorque | 1999 | 32 |
| K970854 | 5 FR and 6 FR Infiniti Angiographic Catheter Class I | 1997 | 7 |
| K051561 | Asahi Angiographic Catheter | 2005 | 2 |
| K181836 | 4F Infiniti Angiographic Catheter, 4F & 5F Nylex Angiography Catheters, 4F & 5F Tempo… | 2018 | 0 |
| K982077 | Selector Diagnostic Catheter | 1998 | 0 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 26, 2006 | Not classified | Z-1240-06 | Other | The tip of the catheter may separate from the body during operation. |
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.
- K9708545 FR and 6 FR Infiniti Angiographic CatheterCordis Corp. · 1997 · Cites it directly · ◆ in the 1997 descendants bar of FIG. 11 Class I recall
What does this lineage say?
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 Cordis 4F Infiniti Angiographic Catheters are intended for the delivery of radiopaque contrast medium 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/K960975 · printed Nov 4, 2026
Cite this page
510(k) Report. “K960975: 1-4F Infiniti 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/K960975
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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