BIO-MEDICUS CANNULA-TUBING

Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

BIO MEDICUS, INC.

The following data is part of a premarket notification filed by Bio Medicus, Inc. with the FDA for Bio-medicus Cannula-tubing.

Pre-market Notification Details

Device IDK872033
510k NumberK872033
Device Name:BIO-MEDICUS CANNULA-TUBING
ClassificationCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Applicant BIO MEDICUS, INC. 9600 W. 76 ST. Eden Prairie,  MN  55344
ContactGregory W Sachs
CorrespondentGregory W Sachs
BIO MEDICUS, INC. 9600 W. 76 ST. Eden Prairie,  MN  55344
Product CodeDWF  
CFR Regulation Number870.4210 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-05-27
Decision Date1987-12-07

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