510(k) K994157 ยท DSP System, Balloon, Intra-Aortic And Control
DATASCOPE'S 8FR. POLYMIDE 25CC,34CC AND 40CC IAB AND ACCESSORIES, MODELS 0684-00-0327, 06844-00-0328, 0684-00-0329
| Applicant | Datascope Corp., Fairfield NJ, US |
| Decision | Substantially Equivalent, Mar 13, 2000 |
| Received | Dec 9, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K994157
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.