Atlas FDA

VENA TECH VENA CAVA FILTER; VENA TECH 30D VENA CAVA FILTER; VENA TECH LP CAVE FILTER

FDA 510(k) clearance K010485 · decided 2001-05-18

Clearance details

K-number
K010485
Device name
VENA TECH VENA CAVA FILTER; VENA TECH 30D VENA CAVA FILTER; VENA TECH LP CAVE FILTER
Applicant
Bbraun
Decision
Substantially Equivalent
Date received
2001-02-20
Decision date
2001-05-18
Days to decision
87 days
Clearance type
Traditional
Product code
DTK
Device class
2
Regulation number
870.3375
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Evanston, IL, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Vena Tech LP Vena Cava Filter System, Item No/REF. 05010024, Model No: 40DLP, B Braun. Man recall (Z-0264-2008)B. Braun Interventional Systems2007-11-24