The following data is part of a premarket notification filed by Biotronik Sales, Inc. with the FDA for Np Bipolar Endocardial Lead W/vs-1 Connector.
| Device ID | K875199 |
| 510k Number | K875199 |
| Device Name: | NP BIPOLAR ENDOCARDIAL LEAD W/VS-1 CONNECTOR |
| Classification | Permanent Pacemaker Electrode |
| Applicant | BIOTRONIK SALES, INC. P.O. BOX 1988 Lake Oswego, OR 97035 -0002 |
| Contact | Richard Stout |
| Correspondent | Richard Stout BIOTRONIK SALES, INC. P.O. BOX 1988 Lake Oswego, OR 97035 -0002 |
| Product Code | DTB |
| CFR Regulation Number | 870.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-12-18 |
| Decision Date | 1988-02-18 |