510(k) K121158 ยท NLH Catheter, Recording, Electrode, Reprocessed
REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS
| Applicant | Sterilmed, Inc., Maple Grove MN, US |
| Decision | Substantially Equivalent, Aug 6, 2012 |
| Received | Apr 16, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121158
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.