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Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Ele…

FDA 510(k)

Class II (US FDA 510(k))

510(k) K241334

by C. R. Bard, Inc.

Identifiers

510(k) Number
K241334 FDA 510(k)
FDA Product Code
LDF FDA 510(k)
Models / Variants
Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 4Fr. (006221P) FDA 510(k)
Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 5Fr. (006225P) FDA 510(k)
Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 6Fr. (006241P) FDA 510(k)
Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 7Fr. (006242P) FDA 510(k)
NBIH™ Temporary Pacing Electrode Catheter, FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.3680 FDA 510(k)
Regulation Number
870.3680 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Ele… by C. R. Bard, Inc. — Class II — FDA_510K — listed in FDA 510(k) — 5 models

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
C. R. Bard, Inc.
FDA Applicant
C.R. Bard, Inc.

Sources (1)

  • FDA 510(k) K241334 24 fields · synced Jun 18, 2026