# K072518: CRS Fibrin Analysis Catheter Testing System (Facts)

- Pathway: 510(k) (Traditional)
- Applicant: Crs Medical Diagnostics, Inc.
- Decided: Dec 20, 2007 after 104 days
- Product code: LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days)
- Device class: 2
- Regulation: 21 CFR 880.5970
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K820771 (1982). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012641: Fas Endoluminal Brush, Fas Medical, Ltd. (2001) Summary page 1.
- K050889: Fibrin Analysis System Endoluminal Brush, Crs Medical Diagnostics, Inc. (2005) Summary page 1.

## Indications for use
The CRS Fibrin Analysis Catheter Testing System (FACTS) is intended to collect and remove obstructing material from the internal lumen surface of an indwelling central venous catheter to restore or improve catheter flow rate, and to provide a biofilm or fibrin sample which is suitable for microbiological analysis.

Source page: https://510kreport.com/device/K072518
Methodology: https://510kreport.com/methodology