The following data is part of a premarket notification filed by Oscor Inc. with the FDA for Temporary Pacing Lead, Series Tbb, Model Helios (tm).
| Device ID | K072770 |
| 510k Number | K072770 |
| Device Name: | TEMPORARY PACING LEAD, SERIES TBB, MODEL HELIOS (TM) |
| Classification | Electrode, Pacemaker, Temporary |
| Applicant | Oscor Inc. 3816 DE SOTO BLVD. Palm Harbor, FL 34683 |
| Contact | Mila Doskocil |
| Correspondent | Mila Doskocil Oscor Inc. 3816 DE SOTO BLVD. Palm Harbor, FL 34683 |
| Product Code | LDF |
| CFR Regulation Number | 870.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-09-28 |
| Decision Date | 2008-01-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885672001537 | K072770 | 000 |
| 00885672001520 | K072770 | 000 |
| 00836559006640 | K072770 | 000 |
| 00836559006633 | K072770 | 000 |