VASCUTEK LTD

Address:Newmains Avenue,Inchinnan Renfrewshire,GB

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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

PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER (DSY) (10)

Premarket Exempt

Clear

MAXIFLO™ - 05037881000213 Catalog Number : S80S06

Device Description : MAXIFLO ePTFE Vascular Prosthesis

Device Class : 2

Duns Number: 229053087

Premarket Exempt : No

Product Code : DSY

Prescription Use : Yes

Device Count : 1

MAXIFLO™ - 05037881000244 Catalog Number : S80S10

Device Description : MAXIFLO ePTFE Vascular Prosthesis

Device Class : 2

Duns Number: 229053087

Premarket Exempt : No

Product Code : DSY

Prescription Use : Yes

Device Count : 1

Gelweave™ - 05037881000251 Catalog Number : 734018/8

Device Description : Gelweave Gelatin Impregnated Woven Vascular Prosthesis ANTE-FLO

Device Class : 2

Duns Number: 229053087

Premarket Exempt : No

Product Code : DSY

Prescription Use : Yes

Device Count : 1

Gelweave™ - 05037881000268 Catalog Number : 732014/8X2

Device Description : Gelweave Gelatin Impregnated Woven Vascular Prosthesis GELWEAVE TRIFURCATE ARCH Y GRAFT

Device Class : 2

Duns Number: 229053087

Premarket Exempt : No

Product Code : DSY

Prescription Use : Yes

Device Count : 1

MAXIFLO™ - 05037881000275 Catalog Number : T10S06

Device Description : MAXIFLO ePTFE Vascular Prosthesis

Device Class : 2

Duns Number: 229053087

Premarket Exempt : No

Product Code : DSY

Prescription Use : Yes

Device Count : 1

MAXIFLO™ - 05037881000299 Catalog Number : T10S08

Device Description : MAXIFLO ePTFE Vascular Prosthesis

Device Class : 2

Duns Number: 229053087

Premarket Exempt : No

Product Code : DSY

Prescription Use : Yes

Device Count : 1

MAXIFLO™ - 05037881000305 Catalog Number : T10S10

Device Description : MAXIFLO ePTFE Vascular Prosthesis

Device Class : 2

Duns Number: 229053087

Premarket Exempt : No

Product Code : DSY

Prescription Use : Yes

Device Count : 1

MAXIFLO™ - 05037881000312 Catalog Number : T20S06

Device Description : MAXIFLO ePTFE Vascular Prosthesis

Device Class : 2

Duns Number: 229053087

Premarket Exempt : No

Product Code : DSY

Prescription Use : Yes

Device Count : 1

MAXIFLO™ - 05037881000329 Catalog Number : T20S08

Device Description : MAXIFLO ePTFE Vascular Prosthesis

Device Class : 2

Duns Number: 229053087

Premarket Exempt : No

Product Code : DSY

Prescription Use : Yes

Device Count : 1

MAXIFLO™ - 05037881000336 Catalog Number : T30S06

Device Description : MAXIFLO ePTFE Vascular Prosthesis

Device Class : 2

Duns Number: 229053087

Premarket Exempt : No

Product Code : DSY

Prescription Use : Yes

Device Count : 1

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