The following data is part of a premarket notification filed by Weck Closure Systems with the FDA for Weck Cardiac Pacing Wires.
| Device ID | K011660 |
| 510k Number | K011660 |
| Device Name: | WECK CARDIAC PACING WIRES |
| Classification | Electrode, Pacemaker, Temporary |
| Applicant | WECK CLOSURE SYSTEMS ONE WECK DR. Research Triangle Park, NC 27709 |
| Contact | Brian Young |
| Correspondent | Brian Young WECK CLOSURE SYSTEMS ONE WECK DR. Research Triangle Park, NC 27709 |
| Product Code | LDF |
| CFR Regulation Number | 870.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-29 |
| Decision Date | 2001-08-21 |
| Summary: | summary |