CS REFSTAR CATHETER (D- AND F-CURVES), MODELS D-1285-01 AND D-1285-02

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 Cs Refstar Catheter (d- And F-curves), Models D-1285-01 And D-1285-02.

Pre-market Notification Details

Device IDK080425
510k NumberK080425
Device Name:CS REFSTAR CATHETER (D- AND F-CURVES), MODELS D-1285-01 AND D-1285-02
ClassificationCatheter, Electrode Recording, Or Probe, Electrode Recording
Applicant BIOSENSE WEBSTER, INC. 3333 DIAMOND CANYON RD. Diamond Bar,  CA  91765
ContactBalaka Das
CorrespondentBalaka Das
BIOSENSE WEBSTER, INC. 3333 DIAMOND CANYON RD. Diamond Bar,  CA  91765
Product CodeDRF  
CFR Regulation Number870.1220 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-02-15
Decision Date2008-04-23
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10846835008807 K080425 000
10846835008791 K080425 000
10846835012620 K080425 000
10846835009989 K080425 000
10846835009972 K080425 000

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