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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
Recalls CDRH Recalls
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