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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Filter, Intravascular, Cardiovascular
510(k) Number K091077
Device Name OPTEASE VENA CAVA FILTER AND RETRIEVAL CATHETER
Applicant
Cordis Corp., A Johnson & Johnson Co.
430 Rte 22 E.
Bridgewater,  NJ  08807
Applicant Contact KAREN WILK
Correspondent
Cordis Corp., A Johnson & Johnson Co.
430 Rte 22 E.
Bridgewater,  NJ  08807
Correspondent Contact KAREN WILK
Regulation Number870.3375
Classification Product Code
DTK  
Date Received04/14/2009
Decision Date 02/04/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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