510(k) K973007 ยท DYB Introducer, Catheter
DATASCOPE'S 10 FR. FLEXISHEATH PERCUTANEOUS INTRODUCER
| Applicant | Datascope Corp., Fairfield NJ, US |
| Decision | Substantially Equivalent, Nov 6, 1997 |
| Received | Aug 13, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K973007
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.