510(k) K243944 ยท PNO Catheter, Percutaneous, Cutting/Scoring
Aperta NSE PTA Balloon Dilatation Catheter
| Applicant | Goodman Co., Ltd., Nagoya, JP |
| Decision | Substantially Equivalent, Apr 22, 2025 |
| Received | Dec 20, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243944
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.