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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 K193015
Device Name HydroPICC (PICC-142)
Applicant
Access Vascular, Inc.
175 Middlesex Turnpike Suite 1a
Bedford,  MA  01730
Applicant Contact Brian Hanley
Correspondent
Access Vascular, Inc.
175 Middlesex Turnpike Suite 1a
Bedford,  MA  01730
Correspondent Contact Brian Hanley
Regulation Number880.5970
Classification Product Code
LJS  
Date Received10/29/2019
Decision Date 02/20/2020
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
Recalls CDRH Recalls
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