510(k) K964987 ยท DSP System, Balloon, Intra-Aortic And Control
DATASCOPE PERCOR STAT - DL 9.5 FR. 25 AND 40CC INTRA-AORTIC BALLOON FOR OPTIONAL SHEATHLESS INSERTION AND PERCOR STAT -0
| Applicant | Datascope Corp., Fairfield NJ, US |
| Decision | Substantially Equivalent, Mar 17, 1997 |
| Received | Dec 13, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964987
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 5, 2003 | Datascope Corp 10.5 Fr. Percor STAT-DL intra-Aortic Balloon Catheter Insertion Kits which contain a Datascope 11.5 Fr. 11'' introducer sheaths. These introducer sheaths include a hemostasis valve and a hub which wo Terminated |
DSP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.