William Cook Europe ApS

Address:SANDET 6,BJAEVERSKOV Sjalland,DK

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

WIRE, GUIDE, CATHETER (DQX) (7) FILTER, INTRAVASCULAR, CARDIOVASCULAR (DTK) (3)

Premarket Exempt

Clear

Cook Celect - 00827002483729 Catalog Number : IGTCFS-65-JUG-CELECT-PERM

Device Description : Cook Celect, Filter Set, Jugular Approach

Device Class : 2

Duns Number: 305302119

Premarket Exempt : No

Product Code : DTK

Prescription Use : Yes

Device Count : 1

Cook Celect - 00827002483736 Catalog Number : IGTCFS-65-FEM-CELECT-PERM

Device Description : Cook Celect, Filter Set, Femoral Approach

Device Class : 2

Duns Number: 305302119

Premarket Exempt : No

Product Code : DTK

Prescription Use : Yes

Device Count : 1

Cook Celect - 00827002483781 Catalog Number : IGTCFS-65-UNI-CELECT-PERM

Device Description : Cook Celect, Filter Set, Femoral and Jugular Approach

Device Class : 2

Duns Number: 305302119

Premarket Exempt : No

Product Code : DTK

Prescription Use : Yes

Device Count : 1

Lunderquist - 00827002492240 Catalog Number : TSMG-35-90-4-LES

Device Description : Lunderquist, Extra Stiff Wire Guide

Device Class : 2

Duns Number: 305302119

Premarket Exempt : No

Product Code : DQX

Prescription Use : Yes

Device Count : 1

Lunderquist - 00827002492257 Catalog Number : TSMG-35-90-7-LES

Device Description : Lunderquist, Extra Stiff Wire Guide

Device Class : 2

Duns Number: 305302119

Premarket Exempt : No

Product Code : DQX

Prescription Use : Yes

Device Count : 1

Lunderquist - 00827002492264 Catalog Number : TSMG-35-145-4-LES

Device Description : Lunderquist, Extra Stiff Wire Guide

Device Class : 2

Duns Number: 305302119

Premarket Exempt : No

Product Code : DQX

Prescription Use : Yes

Device Count : 1

Lunderquist - 00827002492271 Catalog Number : TSMG-35-145-7-LES

Device Description : Lunderquist, Extra Stiff Wire Guide

Device Class : 2

Duns Number: 305302119

Premarket Exempt : No

Product Code : DQX

Prescription Use : Yes

Device Count : 1

Lunderquist - 00827002492288 Catalog Number : TSMG-35-180-7-LES

Device Description : Lunderquist, Extra Stiff Wire Guide

Device Class : 2

Duns Number: 305302119

Premarket Exempt : No

Product Code : DQX

Prescription Use : Yes

Device Count : 1

Lunderquist - 00827002492295 Catalog Number : TSCMG-35-90-7-3-LES

Device Description : Lunderquist, Extra Stiff Wire Guide

Device Class : 2

Duns Number: 305302119

Premarket Exempt : No

Product Code : DQX

Prescription Use : Yes

Device Count : 1

Lunderquist - 00827002492301 Catalog Number : TSCMG-35-180-4-3-LES

Device Description : Lunderquist, Extra Stiff Wire Guide

Device Class : 2

Duns Number: 305302119

Premarket Exempt : No

Product Code : DQX

Prescription Use : Yes

Device Count : 1

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