510(k) K161445 ยท EZD Catheter, Straight
PerfIC Cath Gel S, PerfIC Cath Gel C, PerfIC Cath Hydro S, PerfIC Cath Hydro C
| Applicant | Adapta Medical, Inc., Colorado Springs CO, US |
| Decision | Substantially Equivalent, Aug 16, 2016 |
| Received | May 25, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K161445
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.