510(k) K925248 ยท DSP System, Balloon, Intra-Aortic And Control
MODIFICATION OF INTRA-AORTIC BALLOON CATHETERS
| Applicant | Kontron Instruments, Inc., Everett MA, US |
| Decision | Substantially Equivalent, Sep 27, 1993 |
| Received | Oct 16, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K925248
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.