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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Balloon Aortic Valvuloplasty
510(k) Number K132728
Device Name V8 TRANSLUMINAL BAV CATHETER
Applicant
INTERVALVE, INC
84801 73RD AVENUE NORTH,
SUITE 63
MINNEAPOLIS,  MN  55428
Applicant Contact Sew-Wah Tay
Correspondent
INTERVALVE, INC
84801 73RD AVENUE NORTH,
SUITE 63
MINNEAPOLIS,  MN  55428
Correspondent Contact Sew-Wah Tay
Regulation Number870.1255
Classification Product Code
OZT  
Date Received09/03/2013
Decision Date 11/22/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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