510(k) K940231 ยท DSP System, Balloon, Intra-Aortic And Control
INTRA-AORTIC BALLOON FOR OPTIONAL SHEATHLESS INSERTION
| Applicant | Datascope Corp., Oakland NJ, US |
| Decision | Substantially Equivalent, Sep 13, 1994 |
| Received | Jan 18, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K940231
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.