ABBOTT VASCULAR INC.

Address:Road #2, km 58.0, Cruce Davila,BARCELONETA,PR,00617,US

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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

Catheter, angioplasty, peripheral, transluminal (LIT) (5) STENT, CAROTID (NIM) (5)

Premarket Exempt

No Yes

Clear

XACT - 08717648010316 Catalog Number : 82095-01

Device Description : XACT Carotid Stent System 7.0 mm x 20 mm Straight

Device Class : 3

Duns Number: 964569052

Premarket Exempt : No

Product Code : NIM

Prescription Use : Yes

Device Count : 1

XACT - 08717648010323 Catalog Number : 82096-01

Device Description : XACT Carotid Stent System 10.0 mm x 40 mm Tapered

Device Class : 3

Duns Number: 964569052

Premarket Exempt : No

Product Code : NIM

Prescription Use : Yes

Device Count : 1

XACT - 08717648010330 Catalog Number : 82097-01

Device Description : XACT Carotid Stent System 10.0 mm x 30 mm Tapered

Device Class : 3

Duns Number: 964569052

Premarket Exempt : No

Product Code : NIM

Prescription Use : Yes

Device Count : 1

XACT - 08717648010347 Catalog Number : 82098-01

Device Description : XACT Carotid Stent System 10.0 mm x 30 mm Straight

Device Class : 3

Duns Number: 964569052

Premarket Exempt : No

Product Code : NIM

Prescription Use : Yes

Device Count : 1

XACT - 08717648010354 Catalog Number : 82099-01

Device Description : XACT Carotid Stent System 10.0 mm x 20 mm Straight

Device Class : 3

Duns Number: 964569052

Premarket Exempt : No

Product Code : NIM

Prescription Use : Yes

Device Count : 1

FOX - 08717648010729 Catalog Number : 82144-02

Device Description : FOX sv PTA Catheter 2.0 mm x 20 mm x 90 cm

Device Class : 2

Duns Number: 964569052

Premarket Exempt : No

Product Code : LIT

Prescription Use : Yes

Device Count : 1

FOX - 08717648010743 Catalog Number : 82146-02

Device Description : FOX sv PTA Catheter 2.0 mm x 30 mm x 90 cm

Device Class : 2

Duns Number: 964569052

Premarket Exempt : No

Product Code : LIT

Prescription Use : Yes

Device Count : 1

FOX - 08717648010767 Catalog Number : 82148-02

Device Description : FOX sv PTA Catheter 2.0 mm x 40 mm x 90 cm

Device Class : 2

Duns Number: 964569052

Premarket Exempt : No

Product Code : LIT

Prescription Use : Yes

Device Count : 1

FOX - 08717648010781 Catalog Number : 82150-02

Device Description : FOX sv PTA Catheter 3.0 mm x 20 mm x 90 cm

Device Class : 2

Duns Number: 964569052

Premarket Exempt : No

Product Code : LIT

Prescription Use : Yes

Device Count : 1

FOX - 08717648010804 Catalog Number : 82152-02

Device Description : FOX sv PTA Catheter 3.0 mm x 30 mm x 90 cm

Device Class : 2

Duns Number: 964569052

Premarket Exempt : No

Product Code : LIT

Prescription Use : Yes

Device Count : 1

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