510(k) K202619 ยท LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
KardiFlex PTCA Balloon Dilatation Catheter
| Applicant | Medcaptain Life Science Co., Ltd., Shenzhen, CN |
| Decision | Substantially Equivalent, Apr 29, 2021 |
| Received | Sep 10, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K202619
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.