The following data is part of a premarket notification filed by Siemens-pacesetter, Inc. with the FDA for Silicone Bipolar Lead Models 1136t, 1142t &1146t.
| Device ID | K930876 |
| 510k Number | K930876 |
| Device Name: | SILICONE BIPOLAR LEAD MODELS 1136T, 1142T &1146T |
| Classification | Permanent Pacemaker Electrode |
| Applicant | SIEMENS-PACESETTER, INC. 15900 VALLEY VIEW COURT P.O.BOX 9221 Sylmar, CA 91392 -9221 |
| Contact | Nestor Kusnierz |
| Correspondent | Nestor Kusnierz SIEMENS-PACESETTER, INC. 15900 VALLEY VIEW COURT P.O.BOX 9221 Sylmar, CA 91392 -9221 |
| Product Code | DTB |
| CFR Regulation Number | 870.3680 [🔎] |
| Decision | Se Subject To Tracking Reg (ST) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-02-19 |
| Decision Date | 1994-06-15 |