510(k) K945963 ยท DQT Occluder, Catheter Tip
THE OMNIGUIDE GUIDING CATHETER WITH BALLOON
| Applicant | Micro Interventional Systems, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Feb 8, 1995 |
| Received | Dec 7, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K945963
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.