# K091254: The Crosser 14 Otw Catheter, Model CRU014

- Pathway: 510(k) (Special)
- Applicant: Flowcardia, Inc.
- Decided: May 29, 2009 after 30 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K890505 (1989). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062868: The Crosser Catheter, Model CR1100 and System Electronics, Model FG1002-02, Flowcardia, Inc. (2007) Summary page 1.

## Indications for use
The CROSSER® System is indicated in coronary arteries to facilitate the intra-luminal placement of conventional guidewires beyond chronic total occlusions.

Source page: https://510kreport.com/device/K091254
Methodology: https://510kreport.com/methodology