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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 K031091
Device Name VTI 20 MHZ GATED DOPPLER
Applicant
Vascular Technology Incorporated
175 Cabot St.
Lowell,  MA  01854
Applicant Contact DAVID L REGAN
Correspondent
Entela, Inc.
3033 Madison Ave., SE
Grand Rapids,  MI  49548
Regulation Number870.2100
Classification Product Code
DPW  
Date Received04/07/2003
Decision Date 04/23/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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