All'InCath 035M PTA Balloon Dilatation Catheter AL035P-120-7x80

GUDID 03701261100092

All'InCath 035M PTA Balloon Dilatation Catheter

NEXSTEP MEDICAL

Peripheral angioplasty balloon catheter, basic

• Primary Device ID: 03701261100092
• NIH Device Record Key: 5aa78c2d-4cbf-4257-b76b-f74448927aca
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: All'InCath 035M PTA Balloon Dilatation Catheter
• Version Model Number: 1
• Catalog Number: AL035P-120-7x80
• Company DUNS: 266039102
• Company Name: NEXSTEP MEDICAL
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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

Customer Support Contacts

• Phone: 9999999999
• Email: info@nexstepmedical.com
• Phone: 9999999999
• Email: info@nexstepmedical.com
• Phone: 9999999999
• Email: info@nexstepmedical.com
• Phone: 9999999999
• Email: info@nexstepmedical.com
• Phone: 9999999999
• Email: info@nexstepmedical.com
• Phone: 9999999999
• Email: info@nexstepmedical.com
• Phone: 9999999999
• Email: info@nexstepmedical.com
• Phone: 9999999999
• Email: info@nexstepmedical.com
• Phone: 9999999999
• Email: info@nexstepmedical.com
• Phone: 9999999999
• Email: info@nexstepmedical.com
• Phone: 9999999999
• Email: info@nexstepmedical.com
• Phone: 9999999999
• Email: info@nexstepmedical.com
• Phone: 9999999999
• Email: info@nexstepmedical.com
• Phone: 9999999999
• Email: info@nexstepmedical.com

Device Dimensions

• Catheter Working Length: 120 Millimeter
• Balloon Diameter: 7 Millimeter
• Balloon Length: 80 Millimeter
• Balloon Rated Burst Pressure: 15 Atmosphere
• Introducer Sheath Compatibilit: 7 French
• Guidewire Compatibility: 0.035 French
• Pressure: 1100 Pound per Square Inch
• Balloon Nominal (Inflation) Pr: 11 Atmosphere
• Catheter Working Length: 120 Millimeter
• Balloon Diameter: 7 Millimeter
• Balloon Length: 80 Millimeter
• Balloon Rated Burst Pressure: 15 Atmosphere
• Introducer Sheath Compatibilit: 7 French
• Guidewire Compatibility: 0.035 French
• Pressure: 1100 Pound per Square Inch
• Balloon Nominal (Inflation) Pr: 11 Atmosphere
• Catheter Working Length: 120 Millimeter
• Balloon Diameter: 7 Millimeter
• Balloon Length: 80 Millimeter
• Balloon Rated Burst Pressure: 15 Atmosphere
• Introducer Sheath Compatibilit: 7 French
• Guidewire Compatibility: 0.035 French
• Pressure: 1100 Pound per Square Inch
• Balloon Nominal (Inflation) Pr: 11 Atmosphere
• Catheter Working Length: 120 Millimeter
• Balloon Diameter: 7 Millimeter
• Balloon Length: 80 Millimeter
• Balloon Rated Burst Pressure: 15 Atmosphere
• Introducer Sheath Compatibilit: 7 French
• Guidewire Compatibility: 0.035 French
• Pressure: 1100 Pound per Square Inch
• Balloon Nominal (Inflation) Pr: 11 Atmosphere
• Catheter Working Length: 120 Millimeter
• Balloon Diameter: 7 Millimeter
• Balloon Length: 80 Millimeter
• Balloon Rated Burst Pressure: 15 Atmosphere
• Introducer Sheath Compatibilit: 7 French
• Guidewire Compatibility: 0.035 French
• Pressure: 1100 Pound per Square Inch
• Balloon Nominal (Inflation) Pr: 11 Atmosphere
• Catheter Working Length: 120 Millimeter
• Balloon Diameter: 7 Millimeter
• Balloon Length: 80 Millimeter
• Balloon Rated Burst Pressure: 15 Atmosphere
• Introducer Sheath Compatibilit: 7 French
• Guidewire Compatibility: 0.035 French
• Pressure: 1100 Pound per Square Inch
• Balloon Nominal (Inflation) Pr: 11 Atmosphere
• Catheter Working Length: 120 Millimeter
• Balloon Diameter: 7 Millimeter
• Balloon Length: 80 Millimeter
• Balloon Rated Burst Pressure: 15 Atmosphere
• Introducer Sheath Compatibilit: 7 French
• Guidewire Compatibility: 0.035 French
• Pressure: 1100 Pound per Square Inch
• Balloon Nominal (Inflation) Pr: 11 Atmosphere
• Catheter Working Length: 120 Millimeter
• Balloon Diameter: 7 Millimeter
• Balloon Length: 80 Millimeter
• Balloon Rated Burst Pressure: 15 Atmosphere
• Introducer Sheath Compatibilit: 7 French
• Guidewire Compatibility: 0.035 French
• Pressure: 1100 Pound per Square Inch
• Balloon Nominal (Inflation) Pr: 11 Atmosphere
• Catheter Working Length: 120 Millimeter
• Balloon Diameter: 7 Millimeter
• Balloon Length: 80 Millimeter
• Balloon Rated Burst Pressure: 15 Atmosphere
• Introducer Sheath Compatibilit: 7 French
• Guidewire Compatibility: 0.035 French
• Pressure: 1100 Pound per Square Inch
• Balloon Nominal (Inflation) Pr: 11 Atmosphere
• Catheter Working Length: 120 Millimeter
• Balloon Diameter: 7 Millimeter
• Balloon Length: 80 Millimeter
• Balloon Rated Burst Pressure: 15 Atmosphere
• Introducer Sheath Compatibilit: 7 French
• Guidewire Compatibility: 0.035 French
• Pressure: 1100 Pound per Square Inch
• Balloon Nominal (Inflation) Pr: 11 Atmosphere
• Catheter Working Length: 120 Millimeter
• Balloon Diameter: 7 Millimeter
• Balloon Length: 80 Millimeter
• Balloon Rated Burst Pressure: 15 Atmosphere
• Introducer Sheath Compatibilit: 7 French
• Guidewire Compatibility: 0.035 French
• Pressure: 1100 Pound per Square Inch
• Balloon Nominal (Inflation) Pr: 11 Atmosphere
• Catheter Working Length: 120 Millimeter
• Balloon Diameter: 7 Millimeter
• Balloon Length: 80 Millimeter
• Balloon Rated Burst Pressure: 15 Atmosphere
• Introducer Sheath Compatibilit: 7 French
• Guidewire Compatibility: 0.035 French
• Pressure: 1100 Pound per Square Inch
• Balloon Nominal (Inflation) Pr: 11 Atmosphere
• Catheter Working Length: 120 Millimeter
• Balloon Diameter: 7 Millimeter
• Balloon Length: 80 Millimeter
• Balloon Rated Burst Pressure: 15 Atmosphere
• Introducer Sheath Compatibilit: 7 French
• Guidewire Compatibility: 0.035 French
• Pressure: 1100 Pound per Square Inch
• Balloon Nominal (Inflation) Pr: 11 Atmosphere
• Catheter Working Length: 120 Millimeter
• Balloon Diameter: 7 Millimeter
• Balloon Length: 80 Millimeter
• Balloon Rated Burst Pressure: 15 Atmosphere
• Introducer Sheath Compatibilit: 7 French
• Guidewire Compatibility: 0.035 French
• Pressure: 1100 Pound per Square Inch
• Balloon Nominal (Inflation) Pr: 11 Atmosphere

Device Identifiers

Device Issuing Agency	Device ID
GS1	03701261100092 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191275

FDA Product Code

• LIT: Catheter, Angioplasty, Peripheral, Transluminal

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: 2024-10-09
• Device Publish Date: 2024-10-01