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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, short-term less than 30 days
510(k) Number K220772
Device Name HydroMID 4F Single Lumen Midline Catheter
Applicant
Access Vascular, Inc.
749 Middlesex Turnpike
Billirica,  MA  01821
Applicant Contact Brian M. Hanley
Correspondent
Access Vascular, Inc.
749 Middlesex Turnpike
Billerica,  MA  01821
Correspondent Contact Brian M. Hanley
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received03/16/2022
Decision Date 12/07/2022
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
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