TERUMO ANGIOGRAPHIC CATHETER FOR LAPOROSCOPIC USE

Catheter, Cholangiography

TERUMO MEDICAL CORP.

The following data is part of a premarket notification filed by Terumo Medical Corp. with the FDA for Terumo Angiographic Catheter For Laporoscopic Use.

Pre-market Notification Details

Device IDK926217
510k NumberK926217
Device Name:TERUMO ANGIOGRAPHIC CATHETER FOR LAPOROSCOPIC USE
ClassificationCatheter, Cholangiography
Applicant TERUMO MEDICAL CORP. 125 BLUE BALL RD. Elkton,  MD  21921
ContactSandi Hartka
CorrespondentSandi Hartka
TERUMO MEDICAL CORP. 125 BLUE BALL RD. Elkton,  MD  21921
Product CodeGBZ  
CFR Regulation Number878.4200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-12-10
Decision Date1993-07-13

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