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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 K091006
Device Name ITG VASCULAR ACCESS SYSTEM, MODEL 300
Applicant
Arstasis, Inc.
1021 Howard Ave.
Suite C
San Carlos,  CA  94070
Applicant Contact DOMINIQUE FILLOUX
Correspondent
Arstasis, Inc.
1021 Howard Ave.
Suite C
San Carlos,  CA  94070
Correspondent Contact DOMINIQUE FILLOUX
Regulation Number870.1340
Classification Product Code
DYB  
Date Received04/08/2009
Decision Date 02/25/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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