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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Clamp, Vascular
510(k) Number K170958
Device Name ChitoPulse 9in / 23 cm, ChitoPulse 12in / 30.5 cm, ChitoPulse 15in / 38 cm
Applicant
Tricol Biomedical, Inc.
720 SW Washington St.
Suite 200
Portland,  OR  97205
Applicant Contact Maire Ni Beilliu
Correspondent
Tricol Biomedical, Inc.
720 SW Washington St.
Suite 200
Portland,  OR  97205
Correspondent Contact Maire Ni Beilliu
Regulation Number870.4450
Classification Product Code
DXC  
Date Received03/31/2017
Decision Date 08/29/2017
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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