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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 K970470
Device Name EVT EXPANDABLE SHEATH
Applicant
Guidant Cardiac and Vascular Surgery
1360 O'Brien Dr.
Menlo Park,  CA  94025
Applicant Contact LUANNE TERMEER
Correspondent
Guidant Cardiac and Vascular Surgery
1360 O'Brien Dr.
Menlo Park,  CA  94025
Correspondent Contact LUANNE TERMEER
Regulation Number870.1310
Classification Product Code
DRE  
Date Received02/07/1997
Decision Date 07/31/1997
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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