C.R. Bard, Inc. · Class II · Cleared Jan 31, 2025
| K-number | K241334 |
| Device name | 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, |
| Applicant | C.R. Bard, Inc. |
| Product code | LDF |
| Device class | Class II |
| Decision date | Jan 31, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 870.3680 |
The Bard® Temporary Pacing Electrode Catheter is a bipolar pacing lead designed to transmit electrical signals between an external pulse generator and the heart, or from the heart to a monitoring device, for temporary cardiac pacing. It comes in variants with and without an inflatable balloon, and is packaged with a needle/cannula introducer to facilitate venous insertion.
The subject device features stainless steel electrodes, gold-plated brass electrical connectors with polypropylene overmolding, and a polyurethane shaft with no coating (compared to the predicate's benzalkonium-heparin coating). Available in 4–7 French sizes without balloon and 4–5 French with balloon, in lengths of 100–132 cm overall. Both devices are bipolar, single-use, ethylene oxide sterilized, and non-pyrogenic; the key difference is the absence of anticoagulant coating on the subject device.
ISO 10555-1:2013, IEC 60601-1:2020, IEC 60601-1-2:2020, ISO 80369-1:2018, ISO 80369-7:2021, ISO 80369-20:2015, ISO 10993-1:2018, ISO 11070:2014, and ASTM F640. Testing evaluated biocompatibility, electrical safety, electromagnetic compatibility, connector performance, tensile strength, corrosion resistance, balloon integrity, and functional durability.
The subject device shares the same indications for use (temporary cardiac pacing signal transmission) and nearly identical design features as the predicate USCI® device. Although the subject lacks the BH anticoagulant coating, nonclinical testing and real-world clinical evidence up to 11 days of use demonstrated equivalent safety and performance. The technological differences—primarily the coating removal and minor material/dimensional variations—do not raise different safety or effectiveness questions given the demonstrated performance equivalence across all critical endpoints.
View the full FDA submission: accessdata.fda.gov