The following data is part of a premarket notification filed by Pacesetter Systems with the FDA for Additional Cardiac Pacing Leads #1020 Through 1035.
| Device ID | K870824 |
| 510k Number | K870824 |
| Device Name: | ADDITIONAL CARDIAC PACING LEADS #1020 THROUGH 1035 |
| Classification | Permanent Pacemaker Electrode |
| Applicant | PACESETTER SYSTEMS 12884 BRADLEY AVE. Sylmar, CA 91342 |
| Contact | Nestor Kusnierz |
| Correspondent | Nestor Kusnierz PACESETTER SYSTEMS 12884 BRADLEY AVE. Sylmar, CA 91342 |
| Product Code | DTB |
| CFR Regulation Number | 870.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-01-13 |
| Decision Date | 1987-03-20 |