510(k) K153494 ยท DYB Introducer, Catheter
HQS Introducer (Model 2064-HQS)
| Applicant | Alseal, Besancon, FR |
| Decision | Substantially Equivalent, Aug 25, 2016 |
| Received | Dec 4, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153494
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.