The following data is part of a premarket notification filed by Pacesetter Systems with the FDA for Endocardial Screw-in Lead 859 & 861.
| Device ID | K833824 |
| 510k Number | K833824 |
| Device Name: | ENDOCARDIAL SCREW-IN LEAD 859 & 861 |
| Classification | Permanent Pacemaker Electrode |
| Applicant | PACESETTER SYSTEMS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DTB |
| CFR Regulation Number | 870.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-10-31 |
| Decision Date | 1983-12-01 |