# K171999: Performer Introducer

- Pathway: 510(k) (Special)
- Applicant: Cook Incorporated
- Decided: Jul 31, 2017 after 28 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 4 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K231828: Pounce™ Sheath (2023), 1 descendant of its own
- K252227: Pounce (TM) Sheath (2025), 0 descendants of its own
- K242520: Element Vascular Access System (2024), 0 descendants of its own
- K230631: Kodiak™ Dual Port Coaxial Introducer Kit (2023), 0 descendants of its own
- K173068: Performer Introducer (2017), 0 descendants of its own

## Recalls of this device
- Apr 17, 2025 · Class II · Z-1786-2025: Cook Medical identified that devices from the affected device lots may contain the incorrectly sized introducer sheath.
- Sep 16, 2024 · Class II · Z-0045-2025: Cook Medical is conducting removal of a lot of Check-Flo Performer Introducer Set due to complaints that the white caps that connect the shaft to the hub of these products may disconnect.

## Indications for use
Performer™ Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature.

Source page: https://510kreport.com/device/K171999
Methodology: https://510kreport.com/methodology