Atlas FDA

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

FDA 510(k) clearance K172557 · decided 2017-11-20

Clearance details

K-number
K172557
Device name
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
Applicant
William Cook Europe Aps
Decision
Substantially Equivalent
Date received
2017-08-24
Decision date
2017-11-20
Days to decision
88 days
Clearance type
Traditional
Product code
DTK
Device class
2
Regulation number
870.3375
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Bjaeverskov, DK
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

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Zenith Fenestrated AAA Endovascular Graft (P180001/S017)William Cook Europe Aps2026-05-21
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Zenith Dissection Endovascular System (P180001/S014)William Cook Europe Aps2024-07-19
Zenith Dissection Endovascular System (P180001/S013)William Cook Europe Aps2024-07-09
Zenith Dissection Endovascular System (P180001/S012)William Cook Europe Aps2024-04-29
Zenith® Dissection Endovascular System (P180001/S010)William Cook Europe Aps2023-12-15