Atlas FDA

CORDIS OPTEASE VENA CAVA FILTER, MODELS 466-F220A AND 466-F220B; RETRIEVABLE CATHETER, MODEL 466-C220F

FDA 510(k) clearance K034050 · decided 2004-03-22

Clearance details

K-number
K034050
Device name
CORDIS OPTEASE VENA CAVA FILTER, MODELS 466-F220A AND 466-F220B; RETRIEVABLE CATHETER, MODEL 466-C220F
Applicant
Cordis Corporation
Decision
Substantially Equivalent
Date received
2003-12-30
Decision date
2004-03-22
Days to decision
83 days
Clearance type
Traditional
Product code
DTK
Device class
2
Regulation number
870.3375
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Warren, NJ, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Cordis OPTEASE Retrieval Inferior Vena Cava (IVC) Filter***REF Cat. No.***466F220A and 466 recall (Z-1887-2013)Cordis Corporation2013-08-07