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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 K152150
Device Name V8 Balloon Aortic Valvuloplasty Catheter
Applicant
Intervalve, Inc.
2445 Xenium Ln.
Plymouth,  MN  55441
Applicant Contact Mark Ungs
Correspondent
Libramedical, Inc.
8401 73rd Ave. N.
Suite 63
Minneapolis,  MN  55428
Correspondent Contact Ming Cheng Chew
Regulation Number870.1255
Classification Product Code
OZT  
Date Received08/03/2015
Decision Date 12/18/2015
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
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