# K992347: Cordis Super Torque MB Angiographic Catheter with Radiopaque Marker Bands

- Pathway: 510(k) (Traditional)
- Applicant: Cordis Corp.
- Decided: Oct 8, 1999 after 86 days
- Product code: DQO (Catheter, Intravascular, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 870.1200
- Recalls of this device: 7 (5 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
8 later devices descend from it; 2 cite it directly.
3 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Cordis 5.2 F Super Torque Plus Angiographic Catheter: named in the summary without a submission number
- (no number) Cook Aurous™ Graduated Sizing Catheter: named in the summary without a submission number
- (no number) Guidant EVT AngioScale Angiographic Catheter: named in the summary without a submission number

## Most influential descendants
- K020316: Cordis Trapease Permanent Vena Cava Filter with the Visease Angiographic Vessel Dilator; Models 466-P306AU & 466-P306BU (2002), 6 descendants of its own
- K034050: Cordis Optease Vena Cava Filter, Models 466-F220A and 466-F220B; Retrievable Catheter, Model 466-C220F (2004), 5 descendants of its own
- K162875: Sentry IVC filter (2017), 2 descendants of its own
- K173236: Sentry IVC Filter (2018), 1 descendant of its own
- K091077: Optease Vena Cava Filter and Retrieval Catheter (2010), 1 descendant of its own

## Recalls of this device
- Jul 21, 2021 · Class I · Z-2432-2021: 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 vesse
- Jul 21, 2021 · Class I · Z-2430-2021: 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 vesse
- Jul 21, 2021 · Class I · Z-2431-2021: 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 vesse
- Jul 21, 2021 · Class I · Z-2428-2021: 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 vesse
- Jul 21, 2021 · Class I · Z-2429-2021: 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 vesse
- Nov 21, 2011 · Not classified · Z-0205-2012: 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, 532598
- Nov 21, 2011 · Not classified · Z-0204-2012: 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, 532598

## Indications for use
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.

Source page: https://510kreport.com/device/K992347
Methodology: https://510kreport.com/methodology