The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Usci Bipolar Balloon Pacing Electrode With Bh Coating.
| Device ID | K955712 |
| 510k Number | K955712 |
| Device Name: | USCI BIPOLAR BALLOON PACING ELECTRODE WITH BH COATING |
| Classification | Electrode, Pacemaker, Temporary |
| Applicant | C.R. BARD, INC. 1200 TECHNOLOGY PARK DR. Billerica, MA 01821 |
| Contact | Janet D Benson |
| Correspondent | Janet D Benson C.R. BARD, INC. 1200 TECHNOLOGY PARK DR. Billerica, MA 01821 |
| Product Code | LDF |
| CFR Regulation Number | 870.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-15 |
| Decision Date | 1996-10-11 |
| Summary: | summary |