510(k) K012678 ยท NLH Catheter, Recording, Electrode, Reprocessed
REPROCESSED SEALED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS
| Applicant | Sterilmed, Inc., Maple Grove MN, US |
| Decision | Substantially Equivalent, Aug 14, 2002 |
| Received | Aug 14, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012678
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 13, 2009 | Sterilmed Inc EP Catheter
Model #'s:
BIOD6-DR-005-RT
BIOD6-DR-010-RT
DAI401381
DAI401449
DAI401904
DAI401915 and
EPT7003D
Intended for temporary use during electrophysiology studies for intracardiac sensing, reco Terminated |
NLH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.