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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 K974617
Device Name PERIPHERAL VASCULAR DILATOR
Applicant
Endovascular Instruments, Inc.
1800 E. 900 S.
Salt Lake City,  UT  84108
Applicant Contact JACK SPEER
Correspondent
Endovascular Instruments, Inc.
1800 E. 900 S.
Salt Lake City,  UT  84108
Correspondent Contact JACK SPEER
Regulation Number870.1310
Classification Product Code
DRE  
Date Received12/11/1997
Decision Date 12/01/1998
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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