Bard Peripheral Vascular, Inc.

Address:1625 W 3rd St,TEMPE,AZ,85281,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, BILIARY, DIAGNOSTIC (FGE) (6) CLIP, IMPLANTABLE (FZP) (1) INSTRUMENT, BIOPSY (KNW) (1) PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE (DXZ) (1) PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER (DSY) (1) PROSTHESIS, VASCULAR GRAFT, OF LESS THEN 6MM DIAMETER (DYF) (1) STAPLE, IMPLANTABLE (GDW) (1)

Premarket Exempt

No Yes

Clear

Distaflo® Bypass Grafts - 00801741000164 Catalog Number : DFM8006SC

Device Description : Distaflo® Bypass Graft With Flex Small Beading Small Cuff, 6mm x 80 cm

Device Class : 2

Duns Number: 135057938

Premarket Exempt : No

Product Code : DSY, DYF

Prescription Use : Yes

Device Count : 1

Bard® PTFE Felt - 00801741000195 Catalog Number : 007837

Device Description : Bard® PTFE Felt, 15.2 cm x 15.2 cm

Device Class : 2

Duns Number: 135057938

Premarket Exempt : Yes

Product Code : DXZ

Prescription Use : Yes

Device Count : 1

VACORA® - 00801741000324 Catalog Number : VB14116

Device Description : VACORA® Vacuum Assisted Biopsy System, Biopsy Probe, 14G x 116mm

Device Class : 2

Duns Number: 135057938

Premarket Exempt : No

Product Code : KNW

Prescription Use : Yes

Device Count : 1

UltraClip® II Breast Tissue Marker - 00801741000331 Catalog Number : 861017

Device Description : ULTRACLIP® II breast tissue marker 17g x 10cm needle, titanium ribbon clip

Device Class : 2

Duns Number: 135057938

Premarket Exempt : No

Product Code : FZP, GDW

Prescription Use : Yes

Device Count : 1

Valeo® Balloon Expandable Biliary Stent - 00801741000652 Catalog Number : EV06181CD

Device Description : Valeo® Biliary Stent, 6 mm x 18 mm, 80 cm catheter length

Device Class : 2

Duns Number: 135057938

Premarket Exempt : No

Product Code : FGE

Prescription Use : Yes

Device Count : 1

Valeo® Balloon Expandable Biliary Stent - 00801741000669 Catalog Number : EV06182CD

Device Description : Valeo® Biliary Stent, 6 mm x 18 mm (120 cm delivery catheter)

Device Class : 2

Duns Number: 135057938

Premarket Exempt : No

Product Code : FGE

Prescription Use : Yes

Device Count : 1

Valeo® Balloon Expandable Biliary Stent - 00801741000676 Catalog Number : EV06261CD

Device Description : Valeo® Biliary Stent, 6 mm x 26 mm (80 cm delivery catheter)

Device Class : 2

Duns Number: 135057938

Premarket Exempt : No

Product Code : FGE

Prescription Use : Yes

Device Count : 1

Valeo® Balloon Expandable Biliary Stent - 00801741000683 Catalog Number : EV06262CD

Device Description : Valeo® Biliary Stent, 6 mm x 26 mm (120 cm delivery catheter)

Device Class : 2

Duns Number: 135057938

Premarket Exempt : No

Product Code : FGE

Prescription Use : Yes

Device Count : 1

Valeo® Balloon Expandable Biliary Stent - 00801741000690 Catalog Number : EV06361CD

Device Description : Valeo® Biliary Stent, 6 mm x 36 mm (80 cm delivery catheter)

Device Class : 2

Duns Number: 135057938

Premarket Exempt : No

Product Code : FGE

Prescription Use : Yes

Device Count : 1

Valeo® Balloon Expandable Biliary Stent - 00801741000706 Catalog Number : EV06362CD

Device Description : Valeo® Biliary Stent, 6 mm x 36 mm (120 cm delivery catheter)

Device Class : 2

Duns Number: 135057938

Premarket Exempt : No

Product Code : FGE

Prescription Use : Yes

Device Count : 1

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