# K954205: The Amplatz Thrombectomy Device

- Pathway: 510(k) (Traditional)
- Applicant: Microvena Corp.
- Decided: Aug 13, 1996 after 341 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
No predicates in its family tree.
4 later devices descend from it; 1 cites 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)
- None. The FDA summary names its predicate without a number.
- (no number) Fogarty Arterial Embolectomy Catheters (pre-amendment): named in the summary without a submission number

## Most influential descendants
- K963925: Thrombolytic Brush Catheter (1997), 3 descendants of its own
- 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 Amplatz Thrombectomy Device is intended for mechanical dissolution of acute and subacute thrombus in dialysis fistulae. This device is not intended to be used for the removal of atheroma and is contraindicated in coronary, cerebral, and pulmonary vessels.

Source page: https://510kreport.com/device/K954205
Methodology: https://510kreport.com/methodology