The following data is part of a premarket notification filed by Spectramed, Inc. with the FDA for V-pace(tm) Transluminal Ventricular/ Model Sp5540.
| Device ID | K864507 |
| 510k Number | K864507 |
| Device Name: | V-PACE(TM) TRANSLUMINAL VENTRICULAR/ MODEL SP5540 |
| Classification | Electrode, Pacemaker, Temporary |
| Applicant | SPECTRAMED, INC. 6470 RIVERVIEW TERRACE Minneapolis, MN 55432 |
| Contact | Constance G Bundy |
| Correspondent | Constance G Bundy SPECTRAMED, INC. 6470 RIVERVIEW TERRACE Minneapolis, MN 55432 |
| Product Code | LDF |
| CFR Regulation Number | 870.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-11-14 |
| Decision Date | 1987-03-06 |