Atlas FDA

VENA CAVA FILTER

FDA 510(k) clearance K073528 · decided 2008-02-27

Clearance details

K-number
K073528
Device name
VENA CAVA FILTER
Applicant
Cook Incorporated
Decision
Substantially Equivalent
Date received
2007-12-17
Decision date
2008-02-27
Days to decision
72 days
Clearance type
Special
Product code
DTK
Device class
2
Regulation number
870.3375
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Bloomington, IN, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
COOK CHORIONIC VILLUS SAMPLING SET (P900007/S005)Cook Incorporated2009-04-02
COOK CHORIONIC VILLUS SAMPLING SET (P900007/S006)Cook Incorporated2009-03-05
COOK CHORIONIC VILLUS SAMPLING SET (P900007/S004)Cook Incorporated2008-05-08
COOK CHORIONIC VILLUS SAMPLING (CVS) SET (P900007/S002)Cook Incorporated2000-06-12
COOK CHORIONIC VILLUS SAMPLING SET (P900007/S001)Cook Incorporated1998-07-08
COOK CHORIONIC VILLUS SAMPLING SET (P900007)Cook Incorporated1994-09-30