# K090932: Nexgen Peripheral Mechanical Retrieval Device - 200CM, Model MRD-1000; 80  CM, Model MRD-2000

- Pathway: 510(k) (Traditional)
- Applicant: Nexgen Medical Systems, Inc.
- Decided: Sep 24, 2009 after 175 days
- Product code: QEW (Peripheral Mechanical Thrombectomy With Aspiration)
- Device class: 2
- Regulation: 21 CFR 870.5150
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
7 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K110315: Nexgen Peripheral Mechanical Retrieval Device (2011), 6 descendants of its own
- K192814: Pounce Thrombus Retrieval System (2020), 5 descendants of its own
- K211492: Pounce Thrombectomy System (2021), 4 descendants of its own
- K220501: Pounce Thrombectomy System (2022), 3 descendants of its own
- K231022: Pounce™ Thrombectomy System (2023), 2 descendants of its own

## Indications for use
The NexGen Peripheral Mechanical Retrieval Device (MRD) is indicated for the removal of embolic / thrombotic material, including thrombus and debris, from peripheral arterial blood vessels and peripheral bypass grafts and the removal of thrombus from clotted synthetic dialysis grafts and arterio-venous fistulas.

Source page: https://510kreport.com/device/K090932
Methodology: https://510kreport.com/methodology