FDA Registration Active 🇩🇰 Denmark

Celect Platinum® Vena Cava Filter Set for Femoral and Jugular Vein Approach

Reg #: 3002808486 · FEI: 3002808486 · Expires 2025
Products
1
Proprietary Names
6
Establishment Types
2
Classifications
1

Registration Details

Registration Name
WILLIAM COOK EUROPE APS
Registration Number
3002808486
FEI Number
3002808486
Status
Active
Expiry Year
2025
Initial Importer
No
Address
SANDET 6
City
BJAEVERSKOV Sjalland
Country
DK

Regulatory Submissions

510(k) Number
K233680

Owner / Operator

Firm Name
WILLIAM COOK EUROPE APS
Operator Number
9053266
Address
SANDET 6, DK-4632, --
City
BJAEVERSKOV
State
DK-NOTA
Postal Code
--
Country
DK

US Agent

Business Name
Cook Medical Holdings
Contact Name
Matt Graf
Address
750 Daniels Way
City
BLOOMINGTON
State
IN
ZIP
47404
Country
US
Phone
812 3392235

Products

Device Name Product Code
Filter, Intravascular, Cardiovascular DTK

Proprietary Names

Celect Platinum® Vena Cava Filter Set for Femoral and Jugular Vein Approach Celect Platinum® Vena Cava Filter Set for Femoral Vein Approach Celect Platinum® Vena Cava Filter Set for Jugular Vein Approach Gunther Tulip® Vena Cava Filter Set for Jugular Vein Approach Gunther Tulip® Vena Cava Filter Set for Femoral Vein Approach Gunther Tulip® Vena Cava Filter Set for Femoral and Jugular Vein Approach

Establishment Types

Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device