510(k) · Cleared
Recalled · Class I · 20235 FR and 6 FR 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 Sep 30, 1997 as substantially equivalent to K960975 (Cordis Corp., 1996) and 1 other predicate after a 204-day review. Its family tree reaches back 2 generations to 1992. 1 of the 11 devices in its family, counting itself, has a Class I recall. 7 later devices descend from it. It has been recalled 3 times, including a Class I recall.
- Decided
- Sep 30, 1997
- Review
- 204 days
- Class
- Class II
- Product code
- DQO
- Recalls
- 3 (1 Class I)
- Predicates
- 2
Its longest line of descent runs back 2 generations to K921310 (1992). 3 ancestors in all. 7 later devices descend from it, 4 citing it directly. 1 of the 11 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK921310 Cordis 6 French Paragon Angiographic CatheterCordis Corp. · 1992
- 1 generation backK960975 1-4F Infiniti Angiographic CatheterCordis Corp. · 1996 · Recalled
- This deviceK970854 5 FR and 6 FR Infiniti Angiographic CatheterCordis Corp. · 1997
- Descendant · cites it directly · 2 of its ownK051561 Asahi Angiographic CatheterAsahi Intecc Co., Ltd. · 2005
- Descendant · cites it directly · 1 of its ownK090427 Ursa Angiographic CatheterCurative Medical Technology, Inc. · 2010
- Descendant · 2 generations on · 1 of its ownK082559 Spectranetics Cross-Pilot Turbo Elite Support CatheterSpectranetics Corp. · 2008
- Descendant · cites it directly · 0 of its ownK232573 INFINITI™ Ambi Angiographic CatheterCordis US Corp · 2023
- Descendant · 2 generations on · 0 of its ownK123818 Ursa Angiographic CatheterCurative Medical Technology, Inc. · 2013
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K051561Asahi Angiographic CatheterAsahi Intecc Co., Ltd. · 2005 · cites it directly2descendants
- K090427Ursa Angiographic CatheterCurative Medical Technology, Inc. · 2010 · cites it directly1descendant
- K082559Spectranetics Cross-Pilot Turbo Elite Support CatheterSpectranetics Corp. · 2008 · 2 generations on1descendant
- K232573INFINITI™ Ambi Angiographic CatheterCordis US Corp · 2023 · cites it directly0descendants
- K123818Ursa Angiographic CatheterCurative Medical Technology, Inc. · 2013 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K921310 | Cordis 6 French Paragon Angiographic Catheter | Cordis Corp. | 1992 | — |
| −1 | K960975 | 1-4F Infiniti Angiographic Catheter | Cordis Corp. | 1996 | 1 |
| 0 (this device) | K970854 | 5 FR and 6 FR Infiniti Angiographic Catheter | Cordis Corp. | 1997 | — |
| +1 | K051561 | Asahi Angiographic Catheter | Asahi Intecc Co., Ltd. | 2005 | — |
| +1 | K090427 | Ursa Angiographic Catheter | Curative Medical Technology, Inc. | 2010 | — |
| +2 | K082559 | Spectranetics Cross-Pilot Turbo Elite Support Catheter | Spectranetics Corp. | 2008 | — |
| +1 | K232573 | INFINITI™ Ambi Angiographic Catheter | Cordis US Corp | 2023 | — |
| +2 | K123818 | Ursa Angiographic Catheter | Curative Medical Technology, Inc. | 2013 | — |
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 |
|---|---|---|
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K960975 | 1-4F Infiniti Angiographic CatheterSummary page 1…Proprietary Name: Cordis 5 F Infiniti® Angiographic Catheter Cordis 6 F Infiniti® Angiographic Catheter Name of Predicate Devices 4 F Infiniti® Angiographic Catheter, K960975, April 02, 1996 | 6 F Paragon (Infiniti® ) Angiographic Catheter, K921310/A, Sept. 17, 1992 Classification Class Il Performance… | 1996 |
| * | K921310 | Cordis 6 French Paragon Angiographic CatheterSummary page 1…nfiniti® Angiographic Catheter Name of Predicate Devices 4 F Infiniti® Angiographic Catheter, K960975, April 02, 1996 | 6 F Paragon (Infiniti® ) Angiographic Catheter, K921310/A, Sept. 17, 1992 Classification Class Il Performance Standards Performance standards have not been established by the FDA und… | 1992 |
What descends from it? (7)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 26, 2023 | Class I | Z-0286-2024 | Process control | Non-sterile product labeled as sterile was distributed. |
| Nov 7, 2022 | Class II | Z-0720-2023 | Under Investigation by firm | There is a potential for separation at the male connector. |
| Jun 26, 2006 | Not classified | Z-1240-06 | Other | The tip of the catheter may separate from the body during operation. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 5 years and passes through 1 company; a new generation was cleared every 3.5 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K051561 (Asahi Intecc Co., Ltd., 2005) has gone furthest, with 2 descendants of its own.
- 4 other devices also cite its predicate K960975.
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?
Cordis Angiographic Catheters are designed to deliver 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/K970854 · printed Nov 5, 2026
Cite this page
510(k) Report. “K970854: 5 FR and 6 FR Infiniti Angiographic Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K970854
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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