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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Introducer, Catheter
510(k) Number K170695
Device Name VenaCure EVLT NeverTouch Direct Introducer Sheath
Applicant
AngioDynamics, Inc.
26 Forest St.
Marlborough,  MA  01752
Applicant Contact Robin Fuller
Correspondent
AngioDynamics, Inc.
26 Forest St.
Marlborough,  MA  01752
Correspondent Contact Robin Fuller
Regulation Number870.1340
Classification Product Code
DYB  
Date Received03/07/2017
Decision Date 05/30/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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