510(k) K153397 ยท DQX Wire, Guide, Catheter
S-Wire Guidewire System
| Applicant | Concert Medical, LLC, Norwell MA, US |
| Decision | Substantially Equivalent, Aug 18, 2016 |
| Received | Nov 24, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153397
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.