510(k) K142364 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Barrx RFA Self Sizing Balloon Catheter
| Applicant | Covidien, LLC, Mansfield MA, US |
| Decision | Substantially Equivalent, Oct 1, 2014 |
| Received | Aug 25, 2014 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K142364
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.