# K050889: Fibrin Analysis System Endoluminal Brush

- Pathway: 510(k) (Traditional)
- Applicant: Crs Medical Diagnostics, Inc.
- Decided: Aug 26, 2005 after 142 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: 3 generations back to K820771 (1982). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993614: Fas Endoluminal Brush, Fas Medical, Ltd. (2000) Summary page 1.

## Most influential descendants
- K072518: CRS Fibrin Analysis Catheter Testing System (Facts) (2007), 0 descendants of its own

## Indications for use
The CRS Endoluminal Brush is intended to collect a biofilm or fibrin sample, which is suitable for microbiological analysis, from the inner lumen surface of an in-dwelling central venous catheter The CRS Endoluminal Brush is intended to collect a biofilm or fibrin sample, which is suitable for microbiological analysis, from the inner lumen surface of an in-dwelling central venous catheter

Source page: https://510kreport.com/device/K050889
Methodology: https://510kreport.com/methodology