MICROVASIVE INSURG CHLOANGIOGRAPHIC CATHETER

Catheter, Cholangiography

BOSTON SCIENTIFIC CORP.

The following data is part of a premarket notification filed by Boston Scientific Corp. with the FDA for Microvasive Insurg Chloangiographic Catheter.

Pre-market Notification Details

Device IDK932228
510k NumberK932228
Device Name:MICROVASIVE INSURG CHLOANGIOGRAPHIC CATHETER
ClassificationCatheter, Cholangiography
Applicant BOSTON SCIENTIFIC CORP. 2710 ORCHARD PKWY. San Jose,  CA  95134
ContactSheri D O'brien
CorrespondentSheri D O'brien
BOSTON SCIENTIFIC CORP. 2710 ORCHARD PKWY. San Jose,  CA  95134
Product CodeGBZ  
CFR Regulation Number878.4200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-05-07
Decision Date1993-08-10

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