510(k) K211393 ยท LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
Selethru(TM) NC PTCA Balloon Dilatation Catheter
| Applicant | Kossel Medtech (Suzhou) Co., Ltd., Suzhou, CN |
| Decision | Substantially Equivalent, Jul 2, 2021 |
| Received | May 5, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211393
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.