510(k) K013326 ยท DSP System, Balloon, Intra-Aortic And Control
MODIFICATION TO: DATASCOPE 8FR. POLYIMIDE ALT B IAB, 25CC, 34CC, 40CC, DATASCOPE INSERTION KIT FOR 8 FR, POLYIMIDE ALT B
| Applicant | Datascope Corp., Fairfield NJ, US |
| Decision | Substantially Equivalent, Nov 2, 2001 |
| Received | Oct 5, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K013326
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.