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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name fibrin sealant preparation device
510(k) Number BK180287
Tradename VISTASEAL Airless Spray Accessory
Device Name Fibrin Sealant Preparation Device
Original Applicant
ETHICON Inc.
route 22 west
p.o. box 151
somerville,  NJ  08876
Regulation Number880.5860
Classification Product Code
MZM  
Date Received11/19/2018
Decision Date 04/10/2019
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
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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