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) (5) Catheter, Percutaneous (DQY) (5)

Premarket Exempt

Yes

Clear

PolarCath - B479T50150135010 Catalog Number :

Device Description : Peripheral dilation catheter, over the wire 6F (5.0mm x 150mm, 135cm)

Device Class : 2

Duns Number: 045796615

Premarket Exempt : Yes

Product Code : DQY, LIT

Prescription Use : Yes

Device Count : 1

PolarCath - B479T5040135010 Catalog Number :

Device Description : PolarCath peripheral dilation catheter over the wire 5.5F . ( 5.0mm x 40mm, 135cm)

Device Class : 2

Duns Number: 045796615

Premarket Exempt : Yes

Product Code : DQY, LIT

Prescription Use : Yes

Device Count : 1

PolarCath - B479T60100135010 Catalog Number :

Device Description : PolarCath peripheral dilation catheter over the wire 6F . ( 6.0mm x 100mm, 135cm)

Device Class : 2

Duns Number: 045796615

Premarket Exempt : Yes

Product Code : DQY, LIT

Prescription Use : Yes

Device Count : 1

PolarCath - B479T60150135010 Catalog Number :

Device Description : PolarCath peripheral dilation catheter over the wire 7F . ( 6.0mm x 150mm, 135cm)

Device Class : 2

Duns Number: 045796615

Premarket Exempt : Yes

Product Code : DQY, LIT

Prescription Use : Yes

Device Count : 1

PolarCath - B479T6040135010 Catalog Number :

Device Description : Peripheral dilation catheter, over the wire 6F (6.0mm x 40mm, 135cm)

Device Class : 2

Duns Number: 045796615

Premarket Exempt : Yes

Product Code : DQY, LIT

Prescription Use : Yes

Device Count : 1

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