# K241362: Pounce XL Thrombectomy System (PTS-1011-7F135)

- Pathway: 510(k) (Traditional)
- Applicant: Surmodics,Inc.
- Decided: Sep 11, 2024 after 120 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: 7 generations back to K970657 (1997). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220501: Pounce Thrombectomy System, Surmodics,Inc. (2022) Summary page 5.
- K231022: Pounce™ Thrombectomy System, Surmodics,Inc. (2023) Summary page 5.

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

Source page: https://510kreport.com/device/K241362
Methodology: https://510kreport.com/methodology