Atlas FDA

VENA CAVA FILTER SYSTEMS, MODIFICATION

FDA 510(k) clearance K925679 · decided 1992-11-27

Clearance details

K-number
K925679
Device name
VENA CAVA FILTER SYSTEMS, MODIFICATION
Applicant
B. Braun Vena-Tech
Decision
Substantially Equivalent
Date received
1992-11-10
Decision date
1992-11-27
Days to decision
17 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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Denali™ Vena Cava Filter System – Femoral and Jugular/Subclavian Delivery Kit (K240257)Bd2024-02-29
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Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip Vena Cava Filter Set for Jugular Vein Approach, Günther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach (K211874)William Cook Europe Aps2021-07-28
Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Cook Celect Platinum Vena Cava Filte Set for Jugular Vein Approach, Cook Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach (K211875)William Cook Europe Aps2021-07-28
Sentry IVC Filter (K181202)Novate Medical , Ltd.2018-06-06
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Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach, Gunther Tulip Vena Cava Filter Set for Jugular Vein Approach, Gunther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach (K172557)William Cook Europe Aps2017-11-20
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Recalls involving this device

No recalls on record reference this clearance.