Nucryo Vascular

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 - B479NC30000010 Catalog Number :

Device Description : PolarCath nitrous oxide cartridge 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

PolarCath - B479P4100120010 Catalog Number :

Device Description : PolarCath peripheral dilation catheter over the wire 6F . (4.0mm x 100mm, 120cm)

Device Class : 2

Duns Number: 045796615

Premarket Exempt : Yes

Product Code : DQY, LIT

Prescription Use : Yes

Device Count : 1

PolarCath - B479P4150120010 Catalog Number :

Device Description : PolarCath peripheral dilation catheter over the wire 6F . ( 4.0mm x 150mm, 120cm)

Device Class : 2

Duns Number: 045796615

Premarket Exempt : Yes

Product Code : DQY, LIT

Prescription Use : Yes

Device Count : 1

PolarCath - B479P440120010 Catalog Number :

Device Description : PolarCath peripheral dilation catheter over the wire 6F ( 4.0mm x 40mm, 120cm)

Device Class : 2

Duns Number: 045796615

Premarket Exempt : Yes

Product Code : DQY, LIT

Prescription Use : Yes

Device Count : 1

PolarCath - B479P5100120010 Catalog Number :

Device Description : PolarCath peripheral dilation catheter over the wire 6F . ( 5.0mm x 100mm, 120cm)

Device Class : 2

Duns Number: 045796615

Premarket Exempt : Yes

Product Code : DQY, LIT

Prescription Use : Yes

Device Count : 1

PolarCath - B479P5150120010 Catalog Number :

Device Description : PolarCath peripheral dilation catheter over the wire 6F . ( 5.0mm x 150mm, 120cm)

Device Class : 2

Duns Number: 045796615

Premarket Exempt : Yes

Product Code : DQY, LIT

Prescription Use : Yes

Device Count : 1

PolarCath - B479P540120010 Catalog Number :

Device Description : PolarCath peripheral dilation catheter over the wire 6F . ( 5.0mm x 40mm, 120cm)

Device Class : 2

Duns Number: 045796615

Premarket Exempt : Yes

Product Code : DQY, LIT

Prescription Use : Yes

Device Count : 1

PolarCath - B479P6100120010 Catalog Number :

Device Description : PolarCath peripheral dilation catheter over the wire 7F. ( 6.0mm x 100mm, 120cm)

Device Class : 2

Duns Number: 045796615

Premarket Exempt : Yes

Product Code : LIT, DQY

Prescription Use : Yes

Device Count : 1

PolarCath - B479P6150120010 Catalog Number :

Device Description : PolarCath peripheral dilation catheter over the wire 7F . ( 6.0mm x 150mm, 120cm)

Device Class : 2

Duns Number: 045796615

Premarket Exempt : Yes

Product Code : DQY, LIT

Prescription Use : Yes

Device Count : 1

PolarCath - B479P640120010 Catalog Number :

Device Description : PolarCath peripheral dilation catheter over the wire 7F . ( 6.0mm x 40mm, 120cm)

Device Class : 2

Duns Number: 045796615

Premarket Exempt : Yes

Product Code : DQY, LIT

Prescription Use : Yes

Device Count : 1

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