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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 EAST
BRIDGEWATER,  NJ  08807
Applicant Contact KAREN WILK
Correspondent
CORDIS CORP., A JOHNSON & JOHNSON CO.
430 RTE 22 EAST
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
Recalls CDRH Recalls
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