510(k) K220881 ยท OZT Balloon Aortic Valvuloplasty
INOUE BALLOON A
| Applicant | Toray Industries, Inc., Chuo-Ku, JP |
| Decision | Substantially Equivalent, Dec 18, 2022 |
| Received | Mar 25, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K220881
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.