200 MICRON BLOOD COMPONENT FILTER AND SYRINGE ADAPTER

Set, Blood Transfusion

ARTERIOCYTE MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Arteriocyte Medical Systems, Inc. with the FDA for 200 Micron Blood Component Filter And Syringe Adapter.

Pre-market Notification Details

Device IDK132905
510k NumberK132905
Device Name:200 MICRON BLOOD COMPONENT FILTER AND SYRINGE ADAPTER
ClassificationSet, Blood Transfusion
Applicant ARTERIOCYTE MEDICAL SYSTEMS, INC. 45 SOUTH STREET Hopkinton,  MA  01748
ContactAnn Charest
CorrespondentDavid Yungvirt
PHARMALINK TECHNICAL GROUP, LLC 20 F STREET, NW Washington,  DC  20001
Product CodeBRZ  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2013-09-16
Decision Date2013-10-04
Summary:summary

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