510(k) K864568 ยท DSP System, Balloon, Intra-Aortic And Control
40CC SURGICAL DOUBLE LUMEN BALLOON CATHETER
| Applicant | Aries Medical, Inc., Woburn MA, US |
| Decision | Substantially Equivalent, May 12, 1987 |
| Received | Nov 19, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K864568
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.