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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 K133607
Device Name V8 TRANSLUMINAL BAV CATHETER
Applicant
Intervalve, Inc.
8401 73rd Ave. N.
Suite 63
Minneapolis,  MN  55428
Applicant Contact JULIE BODMER
Correspondent
Intervalve, Inc.
8401 73rd Ave. N.
Suite 63
Minneapolis,  MN  55428
Correspondent Contact JULIE BODMER
Regulation Number870.1255
Classification Product Code
OZT  
Date Received11/25/2013
Decision Date 02/11/2014
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
Recalls CDRH Recalls
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