510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K043509Substantially Equivalent

Gunther Tulip Vena Cava Filter Set

Cook Inc., Bloomington IN / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K043509 is the FDA 510(k) clearance record for GUNTHER TULIP VENA CAVA FILTER SET, a class II device, cleared for Cook, Inc. on under FDA product code DTK (Filter, Intravascular, Cardiovascular). FDA records list 163 510(k) clearances for Cook, Inc., from to . As of , FDA records show no recalls naming K043509.

Clearance record

Decision date
Received
(136 days to decision)
Product code
DTK Filter, Intravascular, Cardiovascular
Regulation
21 CFR 870.3375
Device class
Class II
Review panel
Cardiovascular
Applicant
Cook, Inc. 750 Daniels Way, Bloomington 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 November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DTK, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260