# K973669: Thrombolytic Brush Catheter, Over the Wire (Otw)

- Pathway: 510(k) (Traditional)
- Applicant: Micro Therapeutics, Inc.
- Decided: Feb 6, 1998 after 134 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: 2 generations back to K954205 (1996). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963925: Thrombolytic Brush Catheter, Micro Therapeutics, Inc. (1997) Summary page 2.

## Indications for use
The Micro Therapeutics, Inc. Over the Wire (OTW) Thrombolytic Brush Catheter is intended for percutaneous dissolution of acute thrombus located in arteriovenous (A-V) fistula. The Over the Wire (OTW) Thrombolytic Brush Catheter is designed to augment the area of interface between clot and pharmacologic augment 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 Over the Wire (OTW) 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. If Micro Therapeutics, Inc. intends to recommend its Over the Wire (OTW) Thrombolytic Brush Catheter interface with specific pharmacological agents, Micro Therapeutics will notify the Food and Drug Administration. Micro Therapeutics, Inc. will not promote any such action until the Food and Drug Administration has reviewed and approved such action.

Source page: https://510kreport.com/device/K973669
Methodology: https://510kreport.com/methodology