# K072776: The Crosser System

- Pathway: 510(k) (Traditional)
- Applicant: Flowcardia, Inc.
- Decided: Dec 7, 2007 after 70 days
- Product code: PDU (Catheter For Crossing Total Occlusions)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: 1 (0 Class I)
- 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.
28 later devices descend from it; 5 cite it directly.
0 of 40 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.

## Most influential descendants
- K111338: Wildcat Catheter (2011), 17 descendants of its own
- K122380: Ocelot System (2012), 14 descendants of its own
- K123532: Ocelot Pixl Catheter (2012), 12 descendants of its own
- K140185: Ocelot Catheter, Ocelot Pixl Catheter, Lightbox Console (2014), 7 descendants of its own
- K152275: Pantheris System (2015), 6 descendants of its own

## Recalls of this device
- Jan 9, 2009 · Not classified · Z-0938-2011: Mislabeled expiration date: Some units were mislabeled with a three year shelf life, but the product is validated only for a two year shelf life.

## Indications for use
The CROSSER System is indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions. The device is contraindicated for use in carotid arteries. The CROSSER Catheter is only intended for use with the CROSSER Electronics System. Refer to the CROSSER Electronics System Manual of Operations for proper use.

Source page: https://510kreport.com/device/K072776
Methodology: https://510kreport.com/methodology