Cleared Traditional

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,

K241334 · C.R. Bard, Inc. · Cardiovascular

Jan 2025

Decision

266d

Days

Class 2

Risk

About This 510(k) Submission

K241334 is an FDA 510(k) clearance for the 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,, a Electrode, Pacemaker, Temporary (Class II — Special Controls, product code LDF), submitted by C.R. Bard, Inc. (Covington, US). The FDA issued a Cleared decision on January 31, 2025, 266 days after receiving the submission on May 10, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3680.

Submission Details

510(k) Number	K241334 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 10, 2024
Decision Date	January 31, 2025
Days to Decision	266 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF