# K955712: Usci Bipolar Balloon Pacing Electrode with BH Coating

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Oct 11, 1996 after 301 days
- Product code: LDF (Electrode, Pacemaker, Temporary)
- Device class: 2
- Regulation: 21 CFR 870.3680
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K800298 (1980). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K800298: Usci Bipolar Ballon Pacing Electrode, C.R. Bard, Inc. (1980) Summary page 3.

## Most influential descendants
- K241334: Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 4Fr. (006221P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 5Fr. (006225P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 6Fr. (006241P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 7Fr. (006242P); NBIH™ Temporary Pacing Electrode Catheter, (2025), 1 descendant of its own
- K251186: Bard® Temporary Pacing Electrode Catheter  Needle / Cannula (Introducer) (2025), 0 descendants of its own

## Indications for use
The USCI® Balloon Bipolar Pacing Electrodes and the USCI® Special Care Electrodes (temporary pacing leads) are used to transmit an electrical stimulus from the pulse generator to the heart and/or to transmit an electrical signal from the heart to a recording device. These devices are sold sterile and are for one time use only. In addition to the pacing electrode with BH coating, each catheter is packaged with a needle cannula, an EKG clip, and a syringe to assist in the use of the pacing electrode.

Source page: https://510kreport.com/device/K955712
Methodology: https://510kreport.com/methodology