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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 K143522
Device Name Presto Inflation Device
Applicant
C.R. Bard, Inc.
1625 W. 3rd St.
Tempe,  AZ  85281
Applicant Contact TIMOTHY WADE
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number870.1650
Classification Product Code
MAV  
Date Received12/12/2014
Decision Date 01/12/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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