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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Diagnostic
510(k) Number K901691
Device Name CVIS INSIGHT 15MHZ CATHETERS FOR PERIPHERAL USE
Applicant
Cardiovascular Imaging Systems, Inc.
595 N. Pastoria Ave.
Sunnyvale,  CA  94085
Applicant Contact RUSSELL W FELKEY
Correspondent
Cardiovascular Imaging Systems, Inc.
595 N. Pastoria Ave.
Sunnyvale,  CA  94085
Correspondent Contact RUSSELL W FELKEY
Regulation Number870.1200
Classification Product Code
DQO  
Date Received04/10/1990
Decision Date 07/06/1990
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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