Atlas FDA

OPTEASE VENA CAVA FILTER AND OPTEASE RETRIEVAL CATHTETER

FDA 510(k) clearance K140286 · decided 2014-03-07

Clearance details

K-number
K140286
Device name
OPTEASE VENA CAVA FILTER AND OPTEASE RETRIEVAL CATHTETER
Applicant
Cordis, A Johnson & Johnson Co.
Decision
Substantially Equivalent
Date received
2014-02-05
Decision date
2014-03-07
Days to decision
30 days
Clearance type
Special
Product code
DTK
Device class
2
Regulation number
870.3375
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Fremont, CA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.