# K012641: Fas Endoluminal Brush

- Pathway: 510(k) (Traditional)
- Applicant: Fas Medical, Ltd.
- Decided: Oct 15, 2001 after 63 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). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 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). Our OCR of the scanned summary read K993613, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “FAS Endoluminal Brush”.
- K963925: Thrombolytic Brush Catheter, Micro Therapeutics, Inc. (1997) Summary page 1.

## Cited in the summary but kept off the family tree
- K993816: Baxter Percutaneous Mechanical Thrombectomy (PMT) Device, Models PMT0606FD and PMT1206FD, Baxter Edwards (2000). Our OCR of the scanned summary read K993816, FDA’s number for Baxter Percutaneous Mechanical Thrombectomy (PMT) Device… (Baxter Edwards). Its FDA name has none of the distinctive words the summary uses for the device it names, “Fogarty Adherent Clot Catheter”. Kept off the family tree. Summary page 1.

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

## Indications for use
The FAS Endoluminal Brush 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/K012641
Methodology: https://510kreport.com/methodology