510(k) K232013 ยท PNO Catheter, Percutaneous, Cutting/Scoring
Aperta NSE PTA Balloon Dilatation Catheter (AW18-05040040/AA18-05040040, AW18-09040040/AA18-09040040, AW18-14540040, AW18-05050040/AA18-05050040, AW18-09050040/AA18-09050040, AW18-14550040, AW18-05060040/AA18-05060040, AW18-09060040/AA18-09060040, AW18-14560040 AW18-05070040/AA18-05070040, AW18-0907
| Applicant | Goodman Co., Ltd., Nagoya, JP |
| Decision | Substantially Equivalent, Mar 28, 2024 |
| Received | Jul 6, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K232013
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.