The following data is part of a premarket notification filed by Pacesetter Systems with the FDA for Pacesetter/siemens Pulse Genera W/vs-1 Head Cavity.
| Device ID | K861422 |
| 510k Number | K861422 |
| Device Name: | PACESETTER/SIEMENS PULSE GENERA W/VS-1 HEAD CAVITY |
| Classification | Implantable Pacemaker Pulse-generator |
| 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 | DXY |
| CFR Regulation Number | 870.3610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-04-16 |
| Decision Date | 1986-06-26 |