# K231828: Pounce™ Sheath

- Pathway: 510(k) (Traditional)
- Applicant: Surmodics,Inc.
- Decided: Sep 7, 2023 after 78 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K171999 (2017). 1 ancestor in all.
1 later device descends 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)
- K171999: Performer Introducer, Cook Incorporated (2017) Summary page 4.

## Most influential descendants
- K252227: Pounce (TM) Sheath (2025), 0 descendants of its own

## Indications for use
The Pounce sheath is intended to introduce therapeutic or diagnostic devices into the vasculature.

Source page: https://510kreport.com/device/K231828
Methodology: https://510kreport.com/methodology