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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
510(k) Number K192246
Device Name Biowy PICC Catheter S Kit
Applicant
Biowy Corporation
27031/27002 Vista Ter.
Lake Forest,  CA  92630
Applicant Contact Arthur Lu
Correspondent
Biowy Corporation
27031/27002 Vista Ter.
Lake Forest,  CA  92630
Correspondent Contact Arthur Lu
Regulation Number880.5970
Classification Product Code
LJS  
Date Received08/19/2019
Decision Date 04/30/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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