510(k) K031569 ยท DSP System, Balloon, Intra-Aortic And Control
DATASCOPE CA 40 8FR. IABS, MODEL 0684-00-04XX
| Applicant | Datascope Corp., Fairfield NJ, US |
| Decision | Substantially Equivalent, Jun 10, 2003 |
| Received | May 20, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K031569
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.