BIOCOR SOFTSHELL VENOUS RESERVOIR (BIOCOR SVR)

Reservoir, Blood, Cardiopulmonary Bypass

MINNTECH CORP.

The following data is part of a premarket notification filed by Minntech Corp. with the FDA for Biocor Softshell Venous Reservoir (biocor Svr).

Pre-market Notification Details

Device IDK972017
510k NumberK972017
Device Name:BIOCOR SOFTSHELL VENOUS RESERVOIR (BIOCOR SVR)
ClassificationReservoir, Blood, Cardiopulmonary Bypass
Applicant MINNTECH CORP. 14605 28TH AVE. NORTH Minneapolis,  MN  55447
ContactLynn Lueders
CorrespondentLynn Lueders
MINNTECH CORP. 14605 28TH AVE. NORTH Minneapolis,  MN  55447
Product CodeDTN  
CFR Regulation Number870.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-05-30
Decision Date1997-09-10

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