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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 K203069
Device Name HydroMID
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 Number880.5200
Classification Product Code
FOZ  
Date Received10/09/2020
Decision Date 02/08/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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