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FDA 510(k)

USCI BIPOLAR BALLOON PACING ELECTRODE WITH BH COATING

K-Number: K955712 · 1996-10-11

ApplicantC.R. Bard, Inc.
Decision Date1996-10-11
Product CodeLDF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

USCI BIPOLAR BALLOON PACING ELECTRODE WITH BH COATING is the device name listed in this FDA 510(k) record. The listed applicant is C.R. Bard, Inc.. It received FDA 510(k) clearance on 1996-10-11 under 510(k) number K955712. The device is classified under product code LDF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the USCI BIPOLAR BALLOON PACING ELECTRODE WITH BH COATING?

USCI BIPOLAR BALLOON PACING ELECTRODE WITH BH COATING is a medical device that received FDA 510(k) clearance on 1996-10-11. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K955712.

When did USCI BIPOLAR BALLOON PACING ELECTRODE WITH BH COATING receive FDA 510(k) clearance?

USCI BIPOLAR BALLOON PACING ELECTRODE WITH BH COATING received FDA 510(k) clearance on 1996-10-11, under 510(k) number K955712.

Who is the listed applicant for USCI BIPOLAR BALLOON PACING ELECTRODE WITH BH COATING?

The FDA 510(k) record lists C.R. Bard, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for USCI BIPOLAR BALLOON PACING ELECTRODE WITH BH COATING?

The FDA product code for USCI BIPOLAR BALLOON PACING ELECTRODE WITH BH COATING is LDF.

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Related Devices (Code: LDF)

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K252042Sync AV II Temporary Pacing CatheterSwift Sync, Inc.K242863Bioptimal Bipolar Pacing CatheterBioptimal International Pte. , Ltd.K251186Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer)C.R. Bard, Inc.K241334Semi-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,C.R. Bard, Inc.K241199Rotatable Connector (5944RL)Shenzhen Launch Electrical Co., Ltd.K242705Streamline Unipolar Pediatric Temporary Pacing Lead (6491) Streamline Unipolar Temporary Atrial Pacing Lead (6492) Streamline Unipolar Temporary Myocardial Pacing Wire (6494) Streamline Bipolar Temporary Myocardial Pacing Lead (6495) Streamline Unipolar Temporary Myocardial Pacing Lead (6500)Medtronic, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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