VSI Radial™ introducer sheath

GUDID M20690160

The VSI Radial Introducer Sheath is intended for use to facilitate the introduction of guidewires, catheters and other accessory medical devices through the skin into a vein or artery and minimize blood loss associated with such introduction.

Vascular Solutions, Inc.

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• Primary Device ID: M20690160
• NIH Device Record Key: 2da0c0cf-40f7-4d81-a37a-1c977d555096
• Commercial Distribution Discontinuation: 2019-06-30
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: VSI Radial™ introducer sheath
• Version Model Number: 9016
• 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: true
• 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 Dimensions

• Needle Gauge: 21 Gauge
• Catheter Gauge: 5 French
• Device Size Text, specify: 0
• Needle Gauge: 21 Gauge
• Catheter Gauge: 5 French
• Device Size Text, specify: 0
• Needle Gauge: 21 Gauge
• Catheter Gauge: 5 French
• Device Size Text, specify: 0
• Needle Gauge: 21 Gauge
• Catheter Gauge: 5 French
• Device Size Text, specify: 0
• Needle Gauge: 21 Gauge
• Catheter Gauge: 5 French
• Device Size Text, specify: 0
• Needle Gauge: 21 Gauge
• Catheter Gauge: 5 French
• Device Size Text, specify: 0
• Needle Gauge: 21 Gauge
• Catheter Gauge: 5 French
• Device Size Text, specify: 0
• Needle Gauge: 21 Gauge
• Catheter Gauge: 5 French
• Device Size Text, specify: 0
• Needle Gauge: 21 Gauge
• Catheter Gauge: 5 French
• Device Size Text, specify: 0
• Needle Gauge: 21 Gauge
• Catheter Gauge: 5 French
• Device Size Text, specify: 0
• Needle Gauge: 21 Gauge
• Catheter Gauge: 5 French
• Device Size Text, specify: 0
• Needle Gauge: 21 Gauge
• Catheter Gauge: 5 French
• Device Size Text, specify: 0
• Needle Gauge: 21 Gauge
• Catheter Gauge: 5 French
• Device Size Text, specify: 0
• Needle Gauge: 21 Gauge
• Catheter Gauge: 5 French
• Device Size Text, specify: 0
• Needle Gauge: 21 Gauge
• Catheter Gauge: 5 French
• Device Size Text, specify: 0
• Needle Gauge: 21 Gauge
• Catheter Gauge: 5 French
• Device Size Text, specify: 0
• Needle Gauge: 21 Gauge
• Catheter Gauge: 5 French
• Device Size Text, specify: 0
• Needle Gauge: 21 Gauge

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M20690160 [Primary]
HIBCC	M20690161 [Package]; Package: Box [5 Units]; Discontinued: 2019-06-30; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140768

FDA Product Code

• DYB: Introducer, 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: 5
• Public Version Date: 2019-07-23
• Device Publish Date: 2016-09-05

On-Brand Devices [VSI Radial™ introducer sheath]

• M20690290: 9029
• M20690280: The VSI Radial Introducer Sheath is intended for use to facilitate the introduction of guidewire
• M20690270: The VSI Radial Introducer Sheath is intended for use to facilitate the introduction of guidewire
• M20690260: The VSI Radial Introducer Sheath is intended for use to facilitate the introduction of guidewire
• M20690250: The VSI Radial Introducer Sheath is intended for use to facilitate the introduction of guidewire
• M20690240: The VSI Radial Introducer Sheath is intended for use to facilitate the introduction of guidewire
• M20690230: The VSI Radial Introducer Sheath is intended for use to facilitate the introduction of guidewire
• M20690220: The VSI Radial Introducer Sheath is intended for use to facilitate the introduction of guidewire
• M20690210: The VSI Radial Introducer Sheath is intended for use to facilitate the introduction of guidewire
• M20690190: The VSI Radial Introducer Sheath is intended for use to facilitate the introduction of guidewire
• M20690180: The VSI Radial Introducer Sheath is intended for use to facilitate the introduction of guidewire
• M20690170: The VSI Radial Introducer Sheath is intended for use to facilitate the introduction of guidewire
• M20690160: The VSI Radial Introducer Sheath is intended for use to facilitate the introduction of guidewire
• M20690150: The VSI Radial Introducer Sheath is intended for use to facilitate the introduction of guidewire
• M20690140: The VSI Radial Introducer Sheath is intended for use to facilitate the introduction of guidewire
• M20690130: The VSI Radial Introducer Sheath is intended for use to facilitate the introduction of guidewire
• M20690120: The VSI Radial Introducer Sheath is intended for use to facilitate the introduction of guidewire
• M20690110: The VSI Radial Introducer Sheath is intended for use to facilitate the introduction of guidewire
• M20690100: 9010
• M20690090: 9009
• M20690080: 9008
• M20690070: 9007
• M20690060: 9006
• M20690050: 9005
• M20690040: 9004
• M20690030: 9003
• M20690020: The VSI Radial Introducer Sheath is intended for use to facilitate the introduction of guidewire
• M20690010: The VSI Radial Introducer Sheath is intended for use to facilitate the introduction of guidewire
• M20690000: The VSI Radial Introducer Sheath is intended for use to facilitate the introduction of guidewire
• M20689990: The VSI Radial Introducer Sheath is intended for use to facilitate the introduction of guidewire
• M20689980: The VSI Radial Introducer Sheath is intended for use to facilitate the introduction of guidewire
• M20689970: The VSI Radial Introducer Sheath is intended for use to facilitate the introduction of guidewire
• M20689960: The VSI Radial Introducer Sheath is intended for use to facilitate the introduction of guidewire
• M20689950: The VSI Radial Introducer Sheath is intended for use to facilitate the introduction of guidewire
• M20689940: The VSI Radial Introducer Sheath is intended for use to facilitate the introduction of guidewire
• M20689930: The VSI Radial Introducer Sheath is intended for use to facilitate the introduction of guidewire
• M20689920: The VSI Radial Introducer Sheath is intended for use to facilitate the introduction of guidewire
• M20689910: The VSI Radial Introducer Sheath is intended for use to facilitate the introduction of guidewire
• M20689900: The VSI Radial Introducer Sheath is intended for use to facilitate the introduction of guidewire
• M20689890: The VSI Radial Introducer Sheath is intended for use to facilitate the introduction of guidewire
• M20689880: The VSI Radial Introducer Sheath is intended for use to facilitate the introduction of guidewire
• M20689870: The VSI Radial Introducer Sheath is intended for use to facilitate the introduction of guidewire
• M20689860: The VSI Radial Introducer Sheath is intended for use to facilitate the introduction of guidewire
• M20689850: The VSI Radial Introducer Sheath is intended for use to facilitate the introduction of guidewire