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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Fluoroscopic, Image-Intensified
510(k) Number K970608
Device Name EVT MARKER BOARD
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 Number892.1650
Classification Product Code
JAA  
Date Received02/18/1997
Decision Date 04/21/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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