510(k) K002949 ยท DSP System, Balloon, Intra-Aortic And Control
MODIFICATION TO DATASCOPE PROFILE 8FR. IAB, 34CC; MODIFICATION TO DATASCOPE PROFILE 8FR. IAB, 40CC
| Applicant | Datascope Corp., Fairfield NJ, US |
| Decision | Substantially Equivalent, Oct 20, 2000 |
| Received | Sep 21, 2000 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K002949
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.