510(k) K171999 ยท DYB Introducer, Catheter
Performer Introducer
| Applicant | Cook Incorporated, Bloomington IN, US |
| Decision | Substantially Equivalent, Jul 31, 2017 |
| Received | Jul 3, 2017 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K171999
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 16, 2025 | Cook Incorporated Check=Flo Performer Introducer, 10.0Fr, Reference Part Number(RPN) REF RCFW-10.0-0-38-30-RB, Order Number (GPN) REF G08686, Open, Classified |
DYB | None listed |
| Oct 9, 2024 | Cook Incorporated Check-Flo Performer Introducer Set, Reference Part Number RCF-5.0-35-45-J, Order Number G27242. Performer Introducers are designed to perform as a guiding sheath and/or introducer sheath and come with Open, Classified |
DYB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.