510(k) · Cleared
Recalled · Class I · 2021Cordis Super Torque MB Angiographic Catheter with Radiopaque Marker Bands
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 Oct 8, 1999 after an 86-day review. The FDA summary names its predicate without a number. 3 of the 9 devices in its family, counting itself, have a Class I recall. 8 later devices descend from it. It has been recalled 7 times, including 5 Class I recalls.
- Decided
- Oct 8, 1999
- Review
- 86 days
- Class
- Class II
- Product code
- DQO
- Recalls
- 7 (5 Class I)
- Predicates
- 0
8 later devices descend from it, 2 citing it directly. 3 of the 9 devices in this family, counting this one, have a Class I recall.
- This deviceK992347 Cordis Super Torque MB Angiographic Catheter with Radiopaque Marker…Cordis Corp. · 1999
- Descendant · cites it directly · 6 of its ownK020316 Cordis Trapease Permanent Vena Cava Filter with the Visease…Cordis Corp. · 2002
- Descendant · 2 generations on · 5 of its ownK034050 Cordis Optease Vena Cava Filter, Models 466-F220A and 466-F220B…Cordis Corporation · 2004 · Recalled (Class I)
- Descendant · 3 generations on · 2 of its ownK162875 Sentry IVC filterNovate Medical, Ltd. · 2017
- Descendant · 4 generations on · 1 of its ownK173236 Sentry IVC FilterNovate Medical, Ltd. · 2018
- Descendant · 3 generations on · 1 of its ownK091077 Optease Vena Cava Filter and Retrieval CatheterCordis Corp., A Johnson & Johnson Co. · 2010 · Recalled (Class I)
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 8 · See all- K020316Cordis Trapease Permanent Vena Cava Filter with the Visease Angiographic Vessel Dilator…Cordis Corp. · 2002 · cites it directly6descendants
- K034050Cordis Optease Vena Cava Filter, Models 466-F220A and 466-F220B; Retrievable Catheter…Cordis Corporation · 2004 · 2 generations on5descendants
- K162875Sentry IVC filterNovate Medical, Ltd. · 2017 · 3 generations on2descendants
- K173236Sentry IVC FilterNovate Medical, Ltd. · 2018 · 4 generations on1descendant
- K091077Optease Vena Cava Filter and Retrieval CatheterCordis Corp., A Johnson & Johnson Co. · 2010 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K992347 | Cordis Super Torque MB Angiographic Catheter with Radiopaque Marker Bands | Cordis Corp. | 1999 | — |
| +1 | K020316 | Cordis Trapease Permanent Vena Cava Filter with the Visease Angiographic… | Cordis Corp. | 2002 | — |
| +2 | K034050 | Cordis Optease Vena Cava Filter, Models 466-F220A and 466-F220B; Retrievable… | Cordis Corporation | 2004 | Class I |
| +3 | K162875 | Sentry IVC filter | Novate Medical, Ltd. | 2017 | — |
| +4 | K173236 | Sentry IVC Filter | Novate Medical, Ltd. | 2018 | — |
| +3 | K091077 | Optease Vena Cava Filter and Retrieval Catheter | Cordis Corp., A Johnson & Johnson Co. | 2010 | Class I |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 1 | 1 |
| 2010 | 1 | 1 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2022 | 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.
3 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? (3)
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 |
|---|---|---|---|
| * | — | Cordis 5.2 F Super Torque Plus Angiographic Catheter Named without a submission number | |
| * | — | Cook Aurous™ Graduated Sizing Catheter Named without a submission number | |
| * | — | Guidant EVT AngioScale Angiographic Catheter Named without a submission number |
What descends from it? (8)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 21, 2021 | Class I | Z-2432-2021 | Device Design | Cordis has identified that the SUPER TORQUE MB Angiographic Catheter (with Marker Bands) are being used in a manner that may allow entrapment of the catheter between endovascular devices and the vessel wall, which can lead to marker band… |
| Jul 21, 2021 | Class I | Z-2430-2021 | Device Design | Cordis has identified that the SUPER TORQUE MB Angiographic Catheter (with Marker Bands) are being used in a manner that may allow entrapment of the catheter between endovascular devices and the vessel wall, which can lead to marker band… |
| Jul 21, 2021 | Class I | Z-2431-2021 | Device Design | Cordis has identified that the SUPER TORQUE MB Angiographic Catheter (with Marker Bands) are being used in a manner that may allow entrapment of the catheter between endovascular devices and the vessel wall, which can lead to marker band… |
| Jul 21, 2021 | Class I | Z-2428-2021 | Device Design | Cordis has identified that the SUPER TORQUE MB Angiographic Catheter (with Marker Bands) are being used in a manner that may allow entrapment of the catheter between endovascular devices and the vessel wall, which can lead to marker band… |
| Jul 21, 2021 | Class I | Z-2429-2021 | Device Design | Cordis has identified that the SUPER TORQUE MB Angiographic Catheter (with Marker Bands) are being used in a manner that may allow entrapment of the catheter between endovascular devices and the vessel wall, which can lead to marker band… |
| Nov 21, 2011 | Not classified | Z-0205-2012 | Error in labeling | Cordis Corporation is issuing a Correction for their SUPER TORQUE MB Angiographic Catheter after receiving a report of marker bands dislodged during a procedure. Model Numbers 532598A, 532598B, 532598C, 532598D, SRD5724MB and SRD5727MB… |
| Nov 21, 2011 | Not classified | Z-0204-2012 | Error in labeling | Cordis Corporation is issuing a Correction for their SUPER TORQUE MB Angiographic Catheter after receiving a report of marker bands dislodged during a procedure. Model Numbers 532598A, 532598B, 532598C, 532598D, SRD5724MB and SRD5727MB… |
The 5 latest of 7 recalls; the web page lists all.
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.
- K034050Cordis Optease Vena Cava Filter, Models 466-F220A and 466-F220B; Retrievable Catheter, Model 466-C220FCordis Corporation · 2004 · 2 generations on · ◆ in the 2004 descendants bar of FIG. 11 Class I recall
- K091077Optease Vena Cava Filter and Retrieval CatheterCordis Corp., A Johnson & Johnson Co. · 2010 · 3 generations on · ◆ in the 2010 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K020316 (Cordis Corp., 2002) has gone furthest, with 6 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 Cordis Super Torque MB Angiographic Catheter with Radiopaque Marker Bands is designed to provide angiographic visualization and linear measurement of the vasculature when combined with the delivery of radiopaque 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/K992347 · printed Nov 4, 2026
Cite this page
510(k) Report. “K992347: Cordis Super Torque MB Angiographic Catheter with Radiopaque Marker Bands.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992347
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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