The following data is part of a premarket notification filed by European Custom Manufacturing Bv with the FDA for Temporary Bipolar Myocardial Pacing Wire.
| Device ID | K033858 |
| 510k Number | K033858 |
| Device Name: | TEMPORARY BIPOLAR MYOCARDIAL PACING WIRE |
| Classification | Electrode, Pacemaker, Temporary |
| Applicant | EUROPEAN CUSTOM MANUFACTURING BV OOST-OM 54 NL-5422 VZ Gemert, NL |
| Contact | Maarten Kanters |
| Correspondent | Maarten Kanters EUROPEAN CUSTOM MANUFACTURING BV OOST-OM 54 NL-5422 VZ Gemert, NL |
| Product Code | LDF |
| CFR Regulation Number | 870.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-11 |
| Decision Date | 2004-07-12 |