CORONARY SINUS DEFLECTABLE MAPPING CATHETER, MODEL D-1263-01, WEBSTER CS CATHETER WITH EZ STEER

Catheter, Electrode Recording, Or Probe, Electrode Recording

BIOSENSE WEBSTER, INC.

The following data is part of a premarket notification filed by Biosense Webster, Inc. with the FDA for Coronary Sinus Deflectable Mapping Catheter, Model D-1263-01, Webster Cs Catheter With Ez Steer.

Pre-market Notification Details

Device IDK090898
510k NumberK090898
Device Name:CORONARY SINUS DEFLECTABLE MAPPING CATHETER, MODEL D-1263-01, WEBSTER CS CATHETER WITH EZ STEER
ClassificationCatheter, Electrode Recording, Or Probe, Electrode Recording
Applicant BIOSENSE WEBSTER, INC. 3333 DIAMOND CANYON RD. Diamond Bar,  CA  91765
ContactNatalie Bennington
CorrespondentNatalie Bennington
BIOSENSE WEBSTER, INC. 3333 DIAMOND CANYON RD. Diamond Bar,  CA  91765
Product CodeDRF  
CFR Regulation Number870.1220 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-04-01
Decision Date2009-09-04
Summary:summary

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