Twin-Pass® 023" dual access catheter

GUDID M20652300

The Twin-Pass catheters are intended to be used in conjunction with steerable guidewires in order to access discrete regions of the coronary and peripheral arterial vasculature, to facilitate placement and exchange of guidewires and other interventional devices, and for use during two guidewire procedures. The Twin-Pass .023” catheters are also used to sub selectively infuse/deliver diagnostic or therapeutic agents and to measure intra-arterial pressure within the peripheral vasculature.

Vascular Solutions, Inc.

Peripheral vascular infusion catheter

• Primary Device ID: M20652300
• NIH Device Record Key: 114cd43e-f55b-4c79-8865-8087072f0632
• Commercial Distribution Discontinuation: 2019-04-04
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Twin-Pass® 023" dual access catheter
• Version Model Number: 5230
• 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: 4 French
• Length: 135 Centimeter
• Catheter Gauge: 4 French
• Length: 135 Centimeter
• Catheter Gauge: 4 French
• Length: 135 Centimeter
• Catheter Gauge: 4 French
• Length: 135 Centimeter
• Catheter Gauge: 4 French
• Length: 135 Centimeter
• Catheter Gauge: 4 French
• Length: 135 Centimeter
• Catheter Gauge: 4 French

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M20652300 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062877

FDA Product Code

• DQO: Catheter, Intravascular, Diagnostic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-04-10
• Device Publish Date: 2016-09-05

Devices Manufactured by Vascular Solutions, Inc.

• M20677101 - Vascular Solutions Custom Access Kit: 2023-06-09
• M20677141 - Vascular Solutions Custom Access Kit: 2023-06-09 The Custom Access Kit is intended to introduce up to a 0.038”/0.89mm guidewire or catheter into the vascular system following
• M20677181 - Vascular Solutions Custom Access Kit: 2023-06-09 The Custom Access Kit is intended to introduce up to a 0.038”/0.89mm guidewire or catheter into the vascular system following
• M20677191 - Vascular Solutions Custom Access Kit: 2023-06-09 The Custom Access Kit is intended to introduce up to a 0.038”/0.89mm guidewire or catheter into the vascular system following
• M20677201 - Vascular Solutions Custom Access Kit: 2023-06-09 The Custom Access Kit is intended to introduce up to a 0.038”/0.89mm guidewire or catheter into the vascular system following
• M20677211 - Vascular Solutions Custom Access Kit: 2023-06-09 The Custom Access Kit is intended to introduce up to a 0.038”/0.89mm guidewire or catheter into the vascular system following
• M20677221 - Vascular Solutions Custom Access Kit: 2023-06-09 The Custom Access Kit is intended to introduce up to a 0.038”/0.89mm guidewire or catheter into the vascular system following
• M20677231 - Vascular Solutions Custom Access Kit: 2023-06-09 The Custom Access Kit is intended to introduce up to a 0.038”/0.89mm guidewire or catheter into the vascular system following