The following data is part of a premarket notification filed by Siemens-pacesetter, Inc. with the FDA for Model 1148t Transvenous, Screw-in Lead.
| Device ID | K925347 |
| 510k Number | K925347 |
| Device Name: | MODEL 1148T TRANSVENOUS, SCREW-IN LEAD |
| Classification | Permanent Pacemaker Electrode |
| Applicant | SIEMENS-PACESETTER, INC. 15900 VALLEY VIEW COURT P.O.BOX 9221 Sylmar, CA 91392 -9221 |
| Contact | Linn Eisen |
| Correspondent | Linn Eisen SIEMENS-PACESETTER, INC. 15900 VALLEY VIEW COURT P.O.BOX 9221 Sylmar, CA 91392 -9221 |
| Product Code | DTB |
| CFR Regulation Number | 870.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-10-22 |
| Decision Date | 1993-06-10 |