# K192814: Pounce Thrombus Retrieval System

- Pathway: 510(k) (Traditional)
- Applicant: Surmodics,Inc.
- Decided: Sep 21, 2020 after 356 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
Longest line of descent: 3 generations back to K970657 (1997). 7 ancestors in all.
5 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)
- K110315: Nexgen Peripheral Mechanical Retrieval Device, Nexgen Medical Systems, Inc. (2011) Summary page 4.

## Most influential descendants
- 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
- K241362: Pounce XL Thrombectomy System (PTS-1011-7F135) (2024), 0 descendants of its own

## Indications for use
The Thrombus Retrieval System is intended for the non-surgical removal of thrombi and emboli from the arterial peripheral vasculature.

Source page: https://510kreport.com/device/K192814
Methodology: https://510kreport.com/methodology