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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dilator, Vessel, For Percutaneous Catheterization
510(k) Number K151877
Device Name MicroTract Access System
Applicant
Arstasis, Inc.
6500 Kaiser Dr., Suite 120
Fremont,  CA  94555
Applicant Contact Debra Cogan
Correspondent
Arstasis, Inc.
6500 Kaiser Dr., Suite 120
Fremont,  CA  94555
Correspondent Contact Debra Cogan
Regulation Number870.1310
Classification Product Code
DRE  
Date Received07/09/2015
Decision Date 08/07/2015
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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