510(k) K091449 ยท DSP System, Balloon, Intra-Aortic And Control
DATASCOPE'S 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MODELS 0684,00-0498-01, 02
| Applicant | Datascope Corp., Cardiac Assist Division, Fairfield NJ, US |
| Decision | Substantially Equivalent, Jun 18, 2009 |
| Received | May 18, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K091449
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.