510(k) K212393 ยท LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
OPN NC PTCA Dilatation Catheter
| Applicant | Sis Medical AG, Frauenfeld, CH |
| Decision | Substantially Equivalent, Mar 14, 2022 |
| Received | Aug 2, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212393
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.