The following data is part of a premarket notification filed by Peter M. Rothenberg, M.d. with the FDA for Temporary Transvenous Pacemaker Placement Assist Device.
| Device ID | K032613 |
| 510k Number | K032613 |
| Device Name: | TEMPORARY TRANSVENOUS PACEMAKER PLACEMENT ASSIST DEVICE |
| Classification | Electrode, Pacemaker, Temporary |
| Applicant | PETER M. ROTHENBERG, M.D. 657 CAMINO DE LOS MARES SUITE 137 San Clemente, CA 92673 |
| Contact | Peter M Rothenberg |
| Correspondent | Peter M Rothenberg PETER M. ROTHENBERG, M.D. 657 CAMINO DE LOS MARES SUITE 137 San Clemente, CA 92673 |
| Product Code | LDF |
| CFR Regulation Number | 870.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-08-25 |
| Decision Date | 2003-11-20 |
| Summary: | summary |