510(k) K903344 ยท DSP System, Balloon, Intra-Aortic And Control
9.5 FR PERCUTANEOUS DB LUMEN 40CC FLEXI-CATH (TM)
| Applicant | Kontron Instruments, Inc., Everett MA, US |
| Decision | Substantially Equivalent, Jan 15, 1991 |
| Received | Jul 25, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K903344
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.