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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
510(k) Number K162579
Device Name VascuCel
Applicant
Admedus Regen Pty, Ltd.
26 Harris Rd.
Malaga,  AU 6090
Applicant Contact Mary E. Donlin
Correspondent
Admedus Corporation
860 Blue Gentian Rd. Suite 295
Eagan,  MN  55121
Correspondent Contact Mary E. Donlin
Regulation Number870.3470
Classification Product Code
DXZ  
Date Received09/15/2016
Decision Date 10/14/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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