510(k) K813355 ยท DSP System, Balloon, Intra-Aortic And Control
MODIFICATION OF THE PERCUTAN-BALLOON
| Applicant | Smec, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Jul 2, 1982 |
| Received | Nov 27, 1981 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K813355
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.