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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 K122152
Device Name OXTI INFLATION DEVICE
Applicant
Oxti Corporation
7128 Staffordshire St.
Houston,  TX  77030
Applicant Contact JOSEPH J CHANG
Correspondent
Oxti Corporation
7128 Staffordshire St.
Houston,  TX  77030
Correspondent Contact JOSEPH J CHANG
Regulation Number870.1650
Classification Product Code
MAV  
Date Received07/20/2012
Decision Date 12/14/2012
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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