The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Usci Bipolar Ballon Pacing Electrode.
| Device ID | K800298 |
| 510k Number | K800298 |
| Device Name: | USCI BIPOLAR BALLON PACING ELECTRODE |
| Classification | Electrode, Pacemaker, Temporary |
| Applicant | C.R. BARD, INC. 8195 INDUSTRIAL BLVD. Covington, GA 30014 |
| Contact | Jennifer Rae |
| Correspondent | Jennifer Rae C.R. BARD, INC. 8195 INDUSTRIAL BLVD. Covington, GA 30014 |
| Product Code | LDF |
| CFR Regulation Number | 870.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-02-11 |
| Decision Date | 1980-04-16 |