510(k) K083711 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
MODIFICATION TO: HALO COAGULATION CATHETER, MODELS 32041-18, 32041-20, 32041-22, 32041-25, 32041-28, 32041-31, 32041-34
| Applicant | Barrx Medical, Incorporated, Sunnyvale CA, US |
| Decision | Substantially Equivalent, Feb 2, 2009 |
| Received | Dec 15, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K083711
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.