510(k) K161336 ยท DRE Dilator, Vessel, For Percutaneous Catheterization
VSI StraitSet micro-introducer kit
| Applicant | Vascular Solutions, Inc., Minneapolis MN, US |
| Decision | Substantially Equivalent, Aug 11, 2016 |
| Received | May 13, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161336
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.