510(k) K083335 ยท QEY Mechanical Thrombolysis Catheter
MODIFIED OMNIWAVE ENDOVASCULAR SYSTEM
| Applicant | Omnisonics Medical Technologies, Wilmington MA, US |
| Decision | Substantially Equivalent, Dec 15, 2008 |
| Received | Nov 12, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K083335
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.