# K233397: Cosine-10TM Diagnostic Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic, Inc.
- Decided: Dec 2, 2023 after 60 days
- Product code: DRF (Catheter, Electrode Recording, Or Probe, Electrode Recording)
- Device class: 2
- Regulation: 21 CFR 870.1220
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K983171 (1999). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231312: PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping Catheter, Webster® CS Catheter with Auto ID, Webster® CS Catheter with EZ Steer Technology, Webster® CS Catheter with EZ Steer Technology with Auto ID, Biosense Webster, Inc. (2023) Summary page 5.

## Indications for use
The Cosine-10 Diagnostic Catheter is indicated for electrophysiological mapping (stimulation and recording) of cardiac structures, including in the coronary sinus.

Source page: https://510kreport.com/device/K233397
Methodology: https://510kreport.com/methodology