# K171988: Performer Guiding Sheath

- Pathway: 510(k) (Traditional)
- Applicant: Cook Incorporated
- Decided: Mar 30, 2018 after 270 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: 2 generations back to K004026 (2001). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132720: Heartspan Fixed Curve Braided Transseptal Sheath, Merit Medical Systems, Inc. (2014) Summary page 4.
- K970229: Arrow Transseptal Super Arrow-Flex Percutaneous Set, Arrow Intl., Inc. (1998) Summary page 4.

## Indications for use
Performer™ Introducers and Guiding Sheaths are indicated for the percutaneous introduction of therapeutic or diagnostic devices to all heart chambers, including the left atrium via transseptal puncture.

Source page: https://510kreport.com/device/K171988
Methodology: https://510kreport.com/methodology