USCI BIPOLAR BALLOON PACING ELECTRODE WITH BH COATING

Electrode, Pacemaker, Temporary

C.R. BARD, INC.

The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Usci Bipolar Balloon Pacing Electrode With Bh Coating.

Pre-market Notification Details

Device IDK955712
510k NumberK955712
Device Name:USCI BIPOLAR BALLOON PACING ELECTRODE WITH BH COATING
ClassificationElectrode, Pacemaker, Temporary
Applicant C.R. BARD, INC. 1200 TECHNOLOGY PARK DR. Billerica,  MA  01821
ContactJanet D Benson
CorrespondentJanet D Benson
C.R. BARD, INC. 1200 TECHNOLOGY PARK DR. Billerica,  MA  01821
Product CodeLDF  
CFR Regulation Number870.3680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-12-15
Decision Date1996-10-11
Summary:summary

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