510(k) K882508 ยท DSP System, Balloon, Intra-Aortic And Control
9.5 FRENCH PERCUTANEOUS DOUBLE LUMEN BALLOON
| Applicant | Kontron Instruments, Inc., Everett MA, US |
| Decision | Substantially Equivalent, Mar 20, 1989 |
| Received | Jun 17, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K882508
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.