# K101625: Cohen Crossover Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Vascular Solutions, Inc.
- Decided: Jul 19, 2010 after 40 days
- Product code: DQO (Catheter, Intravascular, Diagnostic)
- 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: 5 generations back to K924607 (1993). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000659: Modification to Softouch Diagnostic Intravascular Cat, Merit Medical Systems, Inc. (2000) Summary page 1.
- K091329: Pinnacle Destination Peripheral Guiding Sheath, Terumo Medical Corp. (2009) Summary page 1.

## Indications for use
The Cohen Crossover Catheter is intended to be used to deliver radiopaque media to selected sites in the vascular system, including the lower extremities using a contralateral approach.

Source page: https://510kreport.com/device/K101625
Methodology: https://510kreport.com/methodology