510(k) K033858 ยท LDF Electrode, Pacemaker, Temporary
TEMPORARY BIPOLAR MYOCARDIAL PACING WIRE
| Applicant | European Custom Manufacturing BV, Gemert, NL |
| Decision | Substantially Equivalent, Jul 12, 2004 |
| Received | Dec 11, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K033858
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 15, 2012 | European Custom Manufacturing B.V. Temporary Pacing Wire, BIPOLAR, Models BM, V, VE and VF, Rx Only, STERILE/EO, Single use only -- Mce (MEDICAL CONCEPTS EUROPE) --- Manufacturer ECM B.V. Oost-Om 54, P.O. Box 53, NL 5420 AB GEMERT --- Terminated |
LDF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.