Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 4Fr. - NBIH™ Temporary Pacing Electrode Catheter,

FDA 510(k)

Class II (US FDA 510(k))

510(k) K241334

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 Electrodes, 115 cm, 4Fr. - NBIH™ Temporary Pacing Electrode Catheter, by C. R.…

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K241334	Class II	Active

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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