SuperCross™ microcatheter

GUDID M20653010

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

• Primary Device ID: M20653010
• NIH Device Record Key: 2963067b-7157-4ace-bb60-ced0ab7195ca
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SuperCross™ microcatheter
• Version Model Number: 5301
• 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

• Catheter Gauge: 1.8 French
• Length: 150 Centimeter
• Catheter Gauge: 1.8 French
• Length: 150 Centimeter
• Catheter Gauge: 1.8 French
• Length: 150 Centimeter
• Catheter Gauge: 1.8 French
• Length: 150 Centimeter
• Catheter Gauge: 1.8 French
• Length: 150 Centimeter
• Catheter Gauge: 1.8 French
• Length: 150 Centimeter
• Catheter Gauge: 1.8 French

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M20653010 [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™ microcatheter]

• M20653010: The SuperCross microcatheter is intended to be used in conjunction with steerable guidewires to
• M20653000: 5300