# K110315: Nexgen Peripheral Mechanical Retrieval Device

- Pathway: 510(k) (Traditional)
- Applicant: Nexgen Medical Systems, Inc.
- Decided: Oct 20, 2011 after 260 days
- Product code: QEZ (Aspiration Thrombectomy Catheter)
- 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
Longest line of descent: 2 generations back to K970657 (1997). 6 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090932: Nexgen Peripheral Mechanical Retrieval Device - 200CM, Model MRD-1000; 80  CM, Model MRD-2000, Nexgen Medical Systems, Inc. (2009) Summary page 5.
- K892410: Fogarty (R) Thru-Lumen Embolectomy Catheter, Baxter Healthcare Corp (1989) Summary page 5.
- K070403: Pronto .035 Extraction Catheter, Vascular Solutions, Inc. (2007) Summary page 5.
- (no number) Fogarty Venous Thrombectomy Catheter: named in the summary without a submission number

## Most influential descendants
- 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
- K260599: INDIGO® Aspiration System – INDIGO Link (2026), 0 descendants of its own

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

Source page: https://510kreport.com/device/K110315
Methodology: https://510kreport.com/methodology