The following data is part of a premarket notification filed by Pacesetter Systems with the FDA for Unipolar Endocardial Screw-in Lead, Model 1007m.
| Device ID | K871208 |
| 510k Number | K871208 |
| Device Name: | UNIPOLAR ENDOCARDIAL SCREW-IN LEAD, MODEL 1007M |
| Classification | Introducer, Catheter |
| Applicant | PACESETTER SYSTEMS 12884 BRADLEY AVE. Sylmar, CA 91342 |
| Contact | Rita Brown |
| Correspondent | Rita Brown PACESETTER SYSTEMS 12884 BRADLEY AVE. Sylmar, CA 91342 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-03-25 |
| Decision Date | 1987-06-05 |