510(k) K980385 ยท DSP System, Balloon, Intra-Aortic And Control
DATASCOPE 8FR. CO-LUMEN 34 AND 40CC INTRA-AORTIC BALLOON CATHETERS FOR OPTIONAL SHEATHLESS INSERTION WITH ACCESSORIES
| Applicant | Datascope Corp., Fairfield NJ, US |
| Decision | Substantially Equivalent, May 1, 1998 |
| Received | Feb 2, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K980385
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.