510(k) K112454 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
HALO60 ABLATION CATHETER
| Applicant | Barrx Medical, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Jan 5, 2012 |
| Received | Aug 25, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K112454
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.