The following data is part of a premarket notification filed by Oscor Inc. with the FDA for Implantable Endocardial Pacing Leads.
| Device ID | K831997 |
| 510k Number | K831997 |
| Device Name: | IMPLANTABLE ENDOCARDIAL PACING LEADS |
| Classification | Permanent Pacemaker Electrode |
| Applicant | Oscor Inc. 3816 DeSoto Blvd. Palm Harbor, FL 34683 |
| Product Code | DTB |
| CFR Regulation Number | 870.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-06-21 |
| Decision Date | 1983-10-20 |