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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Flowmeter, Blood, Cardiovascular
510(k) Number K082870
FOIA Releasable 510(k) K082870
Device Name VTI INTRAOPERATIVE DOPPLER SYSTEMS
Applicant
Vascular Technology Incorporated
12 Murphy Dr.
Nashua,  NH  03062
Applicant Contact DAVID L REGAN
Correspondent
Vascular Technology Incorporated
12 Murphy Dr.
Nashua,  NH  03062
Correspondent Contact DAVID L REGAN
Regulation Number870.2100
Classification Product Code
DPW  
Date Received09/29/2008
Decision Date 10/28/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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