510(k) K162625 ยท LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
SeQuent Neo Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheters
| Applicant | B. Braun Interventional Systems, Inc., Bethlehem PA, US |
| Decision | Substantially Equivalent, Jun 12, 2017 |
| Received | Sep 20, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162625
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.