510(k) K052428 ยท QEY Mechanical Thrombolysis Catheter
RESOLUTION ENDOVASCULAR SYSTEM
| Applicant | Omnisonics Medical Technologies, Wilmington MA, US |
| Decision | Substantially Equivalent, Dec 8, 2005 |
| Received | Sep 2, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K052428
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.