510(k) K020257 ยท DSP System, Balloon, Intra-Aortic And Control
DATASCOPE'S 8FR. ALT B IAB; DATASCOPE'S PROFILE 8FR. ALT B IAB; DATASCOPE'S TRUE SHEATHLESS DL 9.5 FR. IAB; DATASCOPE'S
| Applicant | Datascope Corp., Fairfield NJ, US |
| Decision | Substantially Equivalent, Apr 24, 2002 |
| Received | Jan 24, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K020257
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.