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 - B479P740120010 Catalog Number :

Device Description : PolarCath peripheral dilation catheter over the wire 7F . (7.0mm x 40mm, 120cm)

Device Class : 2

Duns Number: 045796615

Premarket Exempt : Yes

Product Code : DQY, LIT

Prescription Use : Yes

Device Count : 1

PolarCath - B479P840120010 Catalog Number :

Device Description : PolarCath peripheral dilation catheter over the wire 8F. ( 8.0mm x 40mm, 120cm)

Device Class : 2

Duns Number: 045796615

Premarket Exempt : Yes

Product Code : DQY, LIT

Prescription Use : Yes

Device Count : 1

PolarCath - B479PCE10000000 Catalog Number :

Device Description : PolarCath catheter extension for use with PolarCath peripheral dilation system

Device Class :

Duns Number: 045796615

Premarket Exempt : Yes

Product Code : DQY, LIT

Prescription Use : Yes

Device Count : 1

CryoPlasty - B479PCIU5000000 Catalog Number :

Device Description : CryoPlasty inflation unit for use with PolarCath peripheral dilation system

Device Class : 2

Duns Number: 045796615

Premarket Exempt : Yes

Product Code : DQY, LIT

Prescription Use : No

Device Count : 1

PolarCath - B479T20100150010 Catalog Number :

Device Description : PolarCath peripheral dilation catheter over the wire 5F . ( 2.0mm x 100mm, 150cm)

Device Class : 2

Duns Number: 045796615

Premarket Exempt : Yes

Product Code : DQY, LIT

Prescription Use : Yes

Device Count : 1

PolarCath - B479T20150150010 Catalog Number :

Device Description : PolarCath peripheral dilation catheter over the wire 5F . ( 2.0mm x 150mm, 150cm)

Device Class : 2

Duns Number: 045796615

Premarket Exempt : Yes

Product Code : DQY, LIT

Prescription Use : Yes

Device Count : 1

PolarCath - B479T2040150010 Catalog Number :

Device Description : Peripheral dilation catheter, over the wire 5F (2.0mm x 40mm, 150cm)

Device Class : 2

Duns Number: 045796615

Premarket Exempt : Yes

Product Code : DQY, LIT

Prescription Use : Yes

Device Count : 1

PolarCath - B479T25100150010 Catalog Number :

Device Description : PolarCath peripheral dilation catheter over the wire 5F . ( 2.5mm x 100mm, 150cm)

Device Class : 2

Duns Number: 045796615

Premarket Exempt : Yes

Product Code : DQY, LIT

Prescription Use : Yes

Device Count : 1

PolarCath - B479T25150150010 Catalog Number :

Device Description : PolarCath peripheral dilation catheter over the wire 5F . ( 2.5mm x 150mm, 150cm)

Device Class : 2

Duns Number: 045796615

Premarket Exempt : Yes

Product Code : DQY, LIT

Prescription Use : Yes

Device Count : 1

PolarCath - B479T2540150010 Catalog Number :

Device Description : PolarCath peripheral dilation catheter over the wire 5F . ( 2.5mm x 40mm, 150cm)

Device Class : 2

Duns Number: 045796615

Premarket Exempt : Yes

Product Code : DQY, LIT

Prescription Use : Yes

Device Count : 1

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