Atlas FDA

OPTION VENA CAVA FILTER

FDA 510(k) clearance K081410 · decided 2009-06-04

Clearance details

K-number
K081410
Device name
OPTION VENA CAVA FILTER
Applicant
Rex Medical
Decision
Substantially Equivalent
Date received
2008-05-20
Decision date
2009-06-04
Days to decision
380 days
Clearance type
Traditional
Product code
DTK
Device class
2
Regulation number
870.3375
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Northborough, MA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.