VSI Torque Device

GUDID M20681810

The VSI Torque Device is intended for use in manipulating a guidewire that is in the vasculature.

Vascular Solutions, Inc.

Torque manipulation device

• Primary Device ID: M20681810
• NIH Device Record Key: f89b49b2-33ee-4604-bbcf-0f5245354282
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VSI Torque Device
• Version Model Number: 8181
• 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
• 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
• 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 Identifiers

Device Issuing Agency	Device ID
HIBCC	M20681810 [Primary]
HIBCC	M20681811 [Package]; Package: Box [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100093

FDA Product Code

• DQX: Wire, Guide, Catheter

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-11-11
• Device Publish Date: 2016-09-06

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