# K982657: Amplatz Thrombectomy Device Models Atd 601, Atd 602, Atd 801, Atd 802, Foot Pedal Assembly Model AK 100

- Pathway: 510(k) (Traditional)
- Applicant: Microvena Corp.
- Decided: Nov 18, 1998 after 111 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 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) Amplatz Thrombectomy Device: named in the summary without a submission number

## Most influential descendants
- K060016: Thromcat Thrombectomy Catheter System (2006), 1 descendant of its own
- K072195: Thromcat Thrombectomy Catheter System (2007), 0 descendants of its own

## Indications for use
The Amplatz Thrombectomy Device is intended for use in the mechanical dissolution of acute and subacute thrombus within dialysis fistulae.

Source page: https://510kreport.com/device/K982657
Methodology: https://510kreport.com/methodology