VISION HOLLOW FIBER OXYGENATOR WITH GUARDIAN COATING

Oxygenator, Cardiopulmonary Bypass

GISH BIOMEDICAL, INC.

The following data is part of a premarket notification filed by Gish Biomedical, Inc. with the FDA for Vision Hollow Fiber Oxygenator With Guardian Coating.

Pre-market Notification Details

Device IDK023381
510k NumberK023381
Device Name:VISION HOLLOW FIBER OXYGENATOR WITH GUARDIAN COATING
ClassificationOxygenator, Cardiopulmonary Bypass
Applicant GISH BIOMEDICAL, INC. 11874 SOUTH EVELYN CIRCLE Houston,  TX  77071
ContactJ. Harvey Knauss
CorrespondentJ. Harvey Knauss
GISH BIOMEDICAL, INC. 11874 SOUTH EVELYN CIRCLE Houston,  TX  77071
Product CodeDTZ  
CFR Regulation Number870.4350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-10-08
Decision Date2003-03-31
Summary:summary

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