510(k) K182699 ยท LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
Selethru PTCA Balloon Dilatation Catheter
| Applicant | Kossel Medtech (Suzhou) Co., Ltd., Suzhou, CN |
| Decision | Substantially Equivalent, Nov 26, 2018 |
| Received | Sep 27, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182699
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.