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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 K034050
Device Name CORDIS OPTEASE VENA CAVA FILTER, MODELS 466-F220A AND 466-F220B; RETRIEVABLE CATHETER, MODEL 466-C220F
Applicant
Cordis Corporation
7 Powderhorn Dr.
Warren,  NJ  07059
Applicant Contact DONNA MARSHALL
Correspondent
Cordis Corporation
7 Powderhorn Dr.
Warren,  NJ  07059
Correspondent Contact DONNA MARSHALL
Regulation Number870.3375
Classification Product Code
DTK  
Date Received12/30/2003
Decision Date 03/22/2004
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
Recalls CDRH Recalls
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