Skip to content

Performer Introducer

by Cook Incorporated 2 variants

510(k) K171999

Performer Introducer is a medical device (FDA Class II; FDA product code DYB, Introducer, Catheter) made by Cook Incorporated, cleared under FDA 510(k) K171999 on 31 Jul 2017, active as of 22 Oct 2026. 2 FDA recalls are linked to it.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

2 ongoing

This device is named in the recall

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK171999 Date31 Jul 2017ClearedStatusActive

Official records

Recalls

2 recalls · 2 ongoing · FDA

    • Ongoing Z-1786-2025 FDA Class II initiated 17 Apr 2025

    Cook Medical identified that devices from the affected device lots may contain the incorrectly sized introducer sheath.

    • Ongoing Z-0045-2025 FDA Class II initiated 16 Sep 2024

    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.

Timeline

3 dated events

  1. Cleared FDA 510(k) K171999
  2. Recall initiated FDA recalls Z-0045-2025
  3. Recall initiated FDA recalls Z-1786-2025

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
DYB
Device class
Class II
Regulation
21 CFR Part 870.1340
Advisory committee
Cardiovascular
FDA decision
SESE Substantially Equivalent

Related clearances

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Similar devices

Other devices filed under FDA product code DYB (Introducer, Catheter).

Other devices from Cook Incorporated

See all devices from Cook Incorporated →