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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 POWDER HORN DRIVE
WARREN,  NJ  07059
Applicant Contact DONNA MARSHALL
Correspondent
CORDIS CORPORATION
7 POWDER HORN DRIVE
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
Recalls CDRH Recalls
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