SCIMED MEMBRANE OXYGENATOR, MODEL 0600-2A

Oxygenator, Cardiopulmonary Bypass

SCIMED LIFE SYSTEMS, INC.

The following data is part of a premarket notification filed by Scimed Life Systems, Inc. with the FDA for Scimed Membrane Oxygenator, Model 0600-2a.

Pre-market Notification Details

Device IDK883053
510k NumberK883053
Device Name:SCIMED MEMBRANE OXYGENATOR, MODEL 0600-2A
ClassificationOxygenator, Cardiopulmonary Bypass
Applicant SCIMED LIFE SYSTEMS, INC. 13000 COUNTY RD 6 Minneapolis,  MN  55441
ContactSwanson Lano
CorrespondentSwanson Lano
SCIMED LIFE SYSTEMS, INC. 13000 COUNTY RD 6 Minneapolis,  MN  55441
Product CodeDTZ  
CFR Regulation Number870.4350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-07-19
Decision Date1988-09-26

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