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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 K031812
Device Name TRANSVAGINAL DOPPLER CLAMP, MODELS: 09-0016-01, 09-0016-02, 09-0016-03
Applicant
VASCULAR CONTROL SYSTEMS, INC
32236- E PASEO ADELANTO
SAN JUAN CAPISTRANO,  CA  92675
Applicant Contact AL MEMMOLO
Correspondent
VASCULAR CONTROL SYSTEMS, INC
32236- E PASEO ADELANTO
SAN JUAN CAPISTRANO,  CA  92675
Correspondent Contact AL MEMMOLO
Regulation Number870.4450
Classification Product Code
DXC  
Subsequent Product Codes
HHM   ITX   JAF   MDC  
Date Received06/12/2003
Decision Date 12/12/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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