# K231015: Reprocessed Super Torque and Super Torque Plus Diagnostic Angiographic Catheters

- Pathway: 510(k) (Traditional)
- Applicant: Innovative Health, LLC
- Decided: Jul 1, 2024 after 448 days
- Product code: NLI (Catheter, Angiography, Reprocessed)
- Device class: 2
- Regulation: 21 CFR 870.1200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K914007 (1991). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K915836: Cordis 5.0 French Super Torque Catheters, Cordis Corp. (1992) Summary page 5.
- K914007: Cordis 5.2 French Super Torque Plus Cardio Cath, Cordis Corp. (1991) Summary page 5.

## Indications for use
Reprocessed Cordis Catheters are designed to deliver radiopaque contrast medium to selected sites in the vascular system.

Source page: https://510kreport.com/device/K231015
Methodology: https://510kreport.com/methodology