PolarCath

GUDID B479P4100120010

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

Nucryo Vascular

Peripheral angioplasty balloon catheter, basic

• Primary Device ID: B479P4100120010
• NIH Device Record Key: 5129f511-d7cf-4ca0-83e1-d17b7faf9694
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PolarCath
• Version Model Number: P410012001
• Company DUNS: 045796615
• Company Name: Nucryo Vascular
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B479P4100120010 [Primary]

FDA Product Code

• DQY: Catheter, Percutaneous

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-04-19
• Device Publish Date: 2018-03-19

On-Brand Devices [PolarCath]

• B479T6040135010: Peripheral dilation catheter, over the wire 6F (6.0mm x 40mm, 135cm)
• B479T60150135010: PolarCath peripheral dilation catheter over the wire 7F . ( 6.0mm x 150mm, 135cm)
• B479T60100135010: PolarCath peripheral dilation catheter over the wire 6F . ( 6.0mm x 100mm, 135cm)
• B479T5040135010: PolarCath peripheral dilation catheter over the wire 5.5F . ( 5.0mm x 40mm, 135cm)
• B479T50150135010: Peripheral dilation catheter, over the wire 6F (5.0mm x 150mm, 135cm)
• B479T50100135010: Peripheral dilation catheter, over the wire 6F (5.0mm x 100mm, 135cm)
• B479T4040150010: PolarCath peripheral dilation catheter over the wire 5F . ( 4.0mm x 40mm, 150cm)
• B479T40150150010: PolarCath peripheral dilation catheter over the wire 5F . ( 4.0mm x 150mm, 150cm)
• B479T40100150010: PolarCath peripheral dilation catheter over the wire 5F . ( 4.0mm x 100mm, 150cm)
• B479T3540150010: PolarCath peripheral dilation catheter over the wire 5F . ( 3.5mm x 40mm, 150cm)
• B479T35150150010: PolarCath peripheral dilation catheter over the wire 5F . (3.5mm x 150mm, 150cm)
• B479T35100150010: PolarCath peripheral dilation catheter over the wire 5F . ( 3.5mm x 100mm, 150cm)
• B479T3040150010: PolarCath peripheral dilation catheter over the wire 5F . ( 3.0mm x 40mm, 150cm)
• B479T30150150010: PolarCath peripheral dilation catheter over the wire 5F . ( 3.0mm x 150mm, 150cm)
• B479T30100150010: PolarCath peripheral dilation catheter over the wire 5F . ( 3.0mm x 100mm, 150cm)
• B479T2540150010: PolarCath peripheral dilation catheter over the wire 5F . ( 2.5mm x 40mm, 150cm)
• B479T25150150010: PolarCath peripheral dilation catheter over the wire 5F . ( 2.5mm x 150mm, 150cm)
• B479T25100150010: PolarCath peripheral dilation catheter over the wire 5F . ( 2.5mm x 100mm, 150cm)
• B479T2040150010: Peripheral dilation catheter, over the wire 5F (2.0mm x 40mm, 150cm)
• B479T20150150010: PolarCath peripheral dilation catheter over the wire 5F . ( 2.0mm x 150mm, 150cm)
• B479T20100150010: PolarCath peripheral dilation catheter over the wire 5F . ( 2.0mm x 100mm, 150cm)
• B479PCE10000000: PolarCath catheter extension for use with PolarCath peripheral dilation system
• B479P840120010: PolarCath peripheral dilation catheter over the wire 8F. ( 8.0mm x 40mm, 120cm)
• B479P740120010: PolarCath peripheral dilation catheter over the wire 7F . (7.0mm x 40mm, 120cm)
• B479P640120010: PolarCath peripheral dilation catheter over the wire 7F . ( 6.0mm x 40mm, 120cm)
• B479P6150120010: PolarCath peripheral dilation catheter over the wire 7F . ( 6.0mm x 150mm, 120cm)
• B479P6100120010: PolarCath peripheral dilation catheter over the wire 7F. ( 6.0mm x 100mm, 120cm)
• B479P540120010: PolarCath peripheral dilation catheter over the wire 6F . ( 5.0mm x 40mm, 120cm)
• B479P5150120010: PolarCath peripheral dilation catheter over the wire 6F . ( 5.0mm x 150mm, 120cm)
• B479P5100120010: PolarCath peripheral dilation catheter over the wire 6F . ( 5.0mm x 100mm, 120cm)
• B479P440120010: PolarCath peripheral dilation catheter over the wire 6F ( 4.0mm x 40mm, 120cm)
• B479P4150120010: PolarCath peripheral dilation catheter over the wire 6F . ( 4.0mm x 150mm, 120cm)
• B479P4100120010: PolarCath peripheral dilation catheter over the wire 6F . (4.0mm x 100mm, 120cm)
• B479NC30000010: PolarCath nitrous oxide cartridge for use with PolarCath peripheral dilation system