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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous
510(k) Number K971572
Device Name VISTA BRITE TIP CATHETERS
Applicant
Cordis Corp.
14201 NW 60th Ave.
Miami Lakes,  FL  33014
Applicant Contact JACQUELINE ZIMOVAN
Correspondent
Cordis Corp.
14201 NW 60th Ave.
Miami Lakes,  FL  33014
Correspondent Contact JACQUELINE ZIMOVAN
Regulation Number870.1250
Classification Product Code
DQY  
Date Received04/30/1997
Decision Date 07/14/1997
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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