Nucryo Vascular

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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) (10) Catheter, Percutaneous (DQY) (10)

Premarket Exempt

Yes

Clear

PolarCath - B479T30100150010 Catalog Number :

Device Description : PolarCath peripheral dilation catheter over the wire 5F . ( 3.0mm x 100mm, 150cm)

Device Class : 2

Duns Number: 045796615

Premarket Exempt : Yes

Product Code : DQY, LIT

Prescription Use : Yes

Device Count : 1

PolarCath - B479T30150150010 Catalog Number :

Device Description : PolarCath peripheral dilation catheter over the wire 5F . ( 3.0mm x 150mm, 150cm)

Device Class : 2

Duns Number: 045796615

Premarket Exempt : Yes

Product Code : DQY, LIT

Prescription Use : Yes

Device Count : 1

PolarCath - B479T3040150010 Catalog Number :

Device Description : PolarCath peripheral dilation catheter over the wire 5F . ( 3.0mm x 40mm, 150cm)

Device Class : 2

Duns Number: 045796615

Premarket Exempt : Yes

Product Code : LIT, DQY

Prescription Use : Yes

Device Count : 1

PolarCath - B479T35100150010 Catalog Number :

Device Description : PolarCath peripheral dilation catheter over the wire 5F . ( 3.5mm x 100mm, 150cm)

Device Class : 2

Duns Number: 045796615

Premarket Exempt : Yes

Product Code : LIT, DQY

Prescription Use : Yes

Device Count : 1

PolarCath - B479T35150150010 Catalog Number :

Device Description : PolarCath peripheral dilation catheter over the wire 5F . (3.5mm x 150mm, 150cm)

Device Class : 2

Duns Number: 045796615

Premarket Exempt : Yes

Product Code : DQY, LIT

Prescription Use : Yes

Device Count : 1

PolarCath - B479T3540150010 Catalog Number :

Device Description : PolarCath peripheral dilation catheter over the wire 5F . ( 3.5mm x 40mm, 150cm)

Device Class : 2

Duns Number: 045796615

Premarket Exempt : Yes

Product Code : DQY, LIT

Prescription Use : Yes

Device Count : 1

PolarCath - B479T40100150010 Catalog Number :

Device Description : PolarCath peripheral dilation catheter over the wire 5F . ( 4.0mm x 100mm, 150cm)

Device Class : 2

Duns Number: 045796615

Premarket Exempt : Yes

Product Code : DQY, LIT

Prescription Use : Yes

Device Count : 1

PolarCath - B479T40150150010 Catalog Number :

Device Description : PolarCath peripheral dilation catheter over the wire 5F . ( 4.0mm x 150mm, 150cm)

Device Class : 2

Duns Number: 045796615

Premarket Exempt : Yes

Product Code : DQY, LIT

Prescription Use : Yes

Device Count : 1

PolarCath - B479T4040150010 Catalog Number :

Device Description : PolarCath peripheral dilation catheter over the wire 5F . ( 4.0mm x 40mm, 150cm)

Device Class : 2

Duns Number: 045796615

Premarket Exempt : Yes

Product Code : LIT, DQY

Prescription Use : Yes

Device Count : 1

PolarCath - B479T50100135010 Catalog Number :

Device Description : Peripheral dilation catheter, over the wire 6F (5.0mm x 100mm, 135cm)

Device Class : 2

Duns Number: 045796615

Premarket Exempt : Yes

Product Code : DQY, LIT

Prescription Use : Yes

Device Count : 1

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