510(k) K160823 ยท LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
NC Quantum Apex PTCA Dilatation Catheter
| Applicant | Boston Scientific Corporation, Maple Grove MN, US |
| Decision | Substantially Equivalent, Jun 23, 2016 |
| Received | Mar 25, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K160823
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.