The following data is part of a premarket notification filed by Pacesetter Systems with the FDA for Pacesetter Sys, Endocardial, Ventricular, Bipolar.
| Device ID | K850576 |
| 510k Number | K850576 |
| Device Name: | PACESETTER SYS, ENDOCARDIAL, VENTRICULAR, BIPOLAR |
| Classification | Pacemaker Lead Adaptor |
| 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 | DTD |
| CFR Regulation Number | 870.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-02-13 |
| Decision Date | 1985-03-06 |