510(k) K153430 ยท DYB Introducer, Catheter
Flexor Tuohy-Borst Side-Arm Introducers Shuttle Select
| Applicant | Cook Incorporated, Bloomington IN, US |
| Decision | Substantially Equivalent, Mar 7, 2016 |
| Received | Nov 25, 2015 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K153430
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.