Atlas FDA

OPTEASE VENA CAVA FILTER AND RETRIEVAL CATHETER

FDA 510(k) clearance K091077 · decided 2010-02-04

Clearance details

K-number
K091077
Device name
OPTEASE VENA CAVA FILTER AND RETRIEVAL CATHETER
Applicant
Cordis Corp., A Johnson & Johnson Co.
Decision
Substantially Equivalent
Date received
2009-04-14
Decision date
2010-02-04
Days to decision
296 days
Clearance type
Special
Product code
DTK
Device class
2
Regulation number
870.3375
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Bridgewater, NJ, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Cordis OPTEASE Vena Cava Filter Is indicated for use in the prevention of recurrent pulmon recall (Z-0081-2014)Cordis Corporation2013-10-25
Cordis OPTEASE Retrieval Inferior Vena Cava (IVC) Filter***REF Cat. No.***466F220A and 466 recall (Z-1887-2013)Cordis Corporation2013-08-07