510(k) K152310 ยท DRA Catheter, Steerable
HeartLight Deflectable Sheath
| Applicant | Cardiofocus, Inc., Marlborough MA, US |
| Decision | Substantially Equivalent, Feb 24, 2016 |
| Received | Aug 14, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152310
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.