510(k) K232207 · PNO Catheter, Percutaneous, Cutting/Scoring
D·Kutting PTA Scoring Balloon Dilatation Catheter
| Applicant | Dk Medical Technology Co., Ltd., Suzhou, CN |
| Decision | Substantially Equivalent, Mar 7, 2024 |
| Received | Jul 26, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K232207
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.