510(k) K211078 ยท DQO Catheter, Intravascular, Diagnostic
Progreat Lambda
| Applicant | Terumo Clinical Supply Co., Ltd., Kakamigahara, JP |
| Decision | Substantially Equivalent, Dec 21, 2021 |
| Received | Apr 12, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211078
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.