510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K121057Substantially Equivalent

Cook Celect and Gunther Tulip Vena Cava Filter Sets

William Cook Europe ApS, West Lafayette IN / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K121057 is the FDA 510(k) clearance record for COOK CELECT AND GUNTHER TULIP VENA CAVA FILTER SETS, a class II device, cleared for William Cook Europe Aps on under FDA product code DTK (Filter, Intravascular, Cardiovascular). FDA records list 18 510(k) clearances for William Cook Europe Aps, from to . As of , FDA records show no recalls naming K121057.

Clearance record

Decision date
Received
(28 days to decision)
Product code
DTK Filter, Intravascular, Cardiovascular
Regulation
21 CFR 870.3375
Device class
Class II
Review panel
Cardiovascular
Applicant
William Cook Europe Aps One Geddes Way, West Lafayette IN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DTK

Trailing 12 months

FDA records hold no clearances under product code DTK in the trailing twelve months.

FDA records show no clearances under product code DTK in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DTK, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260