510(k) K214009 · LIT Catheter, Angioplasty, Peripheral, Transluminal
D·Kaptain PTA High Pressure Balloon Dilatation Catheter
| Applicant | Dk Medical Technology Co., Ltd., Suzhou, CN |
| Decision | Substantially Equivalent, Apr 5, 2023 |
| Received | Nov 5, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K214009
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.