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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Balloon Inflation
510(k) Number K911295
Device Name ANGIOPLASTY INFLATOR
Applicant
Vastek
401 E. Keowee St.
Dayton,  OH  45404
Applicant Contact ROY A GRIFFIS
Correspondent
Vastek
401 E. Keowee St.
Dayton,  OH  45404
Correspondent Contact ROY A GRIFFIS
Regulation Number870.1650
Classification Product Code
MAV  
Date Received03/25/1991
Decision Date 07/12/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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