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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name device, warming. blood and plasma
510(k) Number BK940022
Tradename Arrow Qwik-1 TM Blood and Fluid Administration Set
Device Name Device, Warming, Blood and Plasma
Original Applicant
Arrow International, Inc.
p.o.box 12888 3000 bernville road
reading,  PA  19612
Regulation Number864.9205
Classification Product Code
KZL  
Date Received03/25/1994
Decision Date 07/14/1994
Decision substantially equivalent (SE)
Classification Advisory Committee Hematology
Review Advisory Committee Hematology
Type 510(k) Traditional
Total Product Life Cycle (TPLC) TPLC Device Report
Reviewed by Third Party No
Expedited Review No
Combination Product No
In Vitro Product No
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