# K963925: Thrombolytic Brush Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Micro Therapeutics, Inc.
- Decided: Aug 8, 1997 after 312 days
- Product code: MCW (Catheter, Peripheral, Atherectomy)
- Device class: 2
- Regulation: 21 CFR 870.4875
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K954205 (1996). 1 ancestor in all.
3 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954205: The Amplatz Thrombectomy Device, Microvena Corp. (1996) Summary page 1.
- (no number) Fogarty® Graft Thrombectomy Catheter (Baxter Corp.): named in the summary without a submission number
- (no number) Mewissen Infusion Catheter (MediTech): named in the summary without a submission number

## Most influential descendants
- K012641: Fas Endoluminal Brush (2001), 1 descendant of its own
- K072518: CRS Fibrin Analysis Catheter Testing System (Facts) (2007), 0 descendants of its own
- K973669: Thrombolytic Brush Catheter, Over the Wire (Otw) (1998), 0 descendants of its own

## Indications for use
The Micro Therapeutics Thrombolytic Brush Catheter is intended for percutaneous dissolution of acute thrombus (i.e., less than two weeks old) located in artificial arteriovenous (A-V) grafts. The Thrombolytic Brush Catheter is designed to augment the area of interface between clot and pharmacologic agent by simultaneous thrombolysis and clot maceration. Clinical studies demonstrate effective dissolution of thrombus in A-V grafts when this product is used in conjunction with urokinase. The Thrombolytic Brush Catheter is not intended for use in native vessels. The device should not be used on patients with a history of significant pulmonary disease or pulmonary hypertension.

Source page: https://510kreport.com/device/K963925
Methodology: https://510kreport.com/methodology