The following data is part of a premarket notification filed by Bio Trace Medical, Inc. with the FDA for Tempo Temporary Pacing Lead.
| Device ID | K160260 |
| 510k Number | K160260 |
| Device Name: | Tempo Temporary Pacing Lead |
| Classification | Electrode, Pacemaker, Temporary |
| Applicant | BIO TRACE MEDICAL, INC. 831 BRANSTEN RD, SUITE L San Carlos, CA 94070 |
| Contact | Laura N. Dietch |
| Correspondent | Laura N. Dietch BIO TRACE MEDICAL, INC. 831 BRANSTEN RD, SUITE L San Carlos, CA 94070 |
| Product Code | LDF |
| CFR Regulation Number | 870.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-01 |
| Decision Date | 2016-10-25 |
| Summary: | summary |