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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 K103421
Device Name ARSTASIS DILATOR ADAPTER
Applicant
Arstasis, Inc.
1021 Howard Ave.
Suite C
San Carlos,  CA  94070
Applicant Contact DEBRA COGAN
Correspondent
Arstasis, Inc.
1021 Howard Ave.
Suite C
San Carlos,  CA  94070
Correspondent Contact DEBRA COGAN
Regulation Number870.1310
Classification Product Code
DRE  
Date Received11/22/2010
Decision Date 05/24/2011
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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