510(k) K170616 ยท DRE Dilator, Vessel, For Percutaneous Catheterization
van Andel Dilatation Catheter
| Applicant | Cook Incorporated, Bloomington IN, US |
| Decision | Substantially Equivalent, Apr 28, 2017 |
| Received | Mar 1, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170616
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.