510(k) K002627 ยท DXE Catheter, Embolectomy
ATRIUM MEDICAL CORPORATION CLEARWAY PTFE BALLOON CATHETER
| Applicant | Atrium Medical Corp., Hudson NH, US |
| Decision | Substantially Equivalent, Apr 26, 2001 |
| Received | Aug 23, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K002627
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.