SuperCross™ AT microcatheter

GUDID M20653020

The SuperCross microcatheter is intended to be used in conjunction with steerable guidewires to access discrete regions of the coronary and/or peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices and to subselectively infuse/deliver diagnostic and therapeutic agents.

Vascular Solutions, Inc.

Peripheral vascular infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter

• Primary Device ID: M20653020
• NIH Device Record Key: 9407c09c-ddba-4e83-9764-d292a296a782
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SuperCross™ AT microcatheter
• Version Model Number: 5302
• Company DUNS: 008999906
• Company Name: Vascular Solutions, Inc.
• 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: 888-240-6001
• Email: customerservice@vasc.com
• Phone: 888-240-6001
• Email: customerservice@vasc.com
• Phone: 888-240-6001
• Email: customerservice@vasc.com
• Phone: 888-240-6001
• Email: customerservice@vasc.com
• Phone: 888-240-6001
• Email: customerservice@vasc.com
• Phone: 888-240-6001
• Email: customerservice@vasc.com
• Phone: 888-240-6001
• Email: customerservice@vasc.com

Device Dimensions

• Length: 130 Centimeter
• Angle: 45 degree
• Length: 130 Centimeter
• Angle: 45 degree
• Length: 130 Centimeter
• Angle: 45 degree
• Length: 130 Centimeter
• Angle: 45 degree
• Length: 130 Centimeter
• Angle: 45 degree
• Length: 130 Centimeter
• Angle: 45 degree
• Length: 130 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M20653020 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101659

FDA Product Code

• DQY: Catheter, Percutaneous

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-04-09
• Device Publish Date: 2016-09-05

On-Brand Devices [SuperCross™ AT microcatheter]

• M20653090: The SuperCross microcatheter is intended to be used in conjunction with steerable guidewires to
• M20653080: The SuperCross microcatheter is intended to be used in conjunction with steerable guidewires to
• M20653070: The SuperCross microcatheter is intended to be used in conjunction with steerable guidewires to
• M20653060: The SuperCross microcatheter is intended to be used in conjunction with steerable guidewires to
• M20653050: The SuperCross microcatheter is intended to be used in conjunction with steerable guidewires to
• M20653040: The SuperCross microcatheter is intended to be used in conjunction with steerable guidewires to
• M20653030: The SuperCross microcatheter is intended to be used in conjunction with steerable guidewires to
• M20653020: The SuperCross microcatheter is intended to be used in conjunction with steerable guidewires to