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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dilator, Vessel, For Percutaneous Catheterization
510(k) Number K913027
Device Name VESSEL DILATOR
Applicant
Deseret Medical, Inc.
9450 S. State St.
Sandy,  UT  84070
Applicant Contact BECTON DICKINSON
Correspondent
Deseret Medical, Inc.
9450 S. State St.
Sandy,  UT  84070
Correspondent Contact BECTON DICKINSON
Regulation Number870.1310
Classification Product Code
DRE  
Date Received07/09/1991
Decision Date 11/27/1991
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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