VSI Radial™ introducer sheath

Basic Information

• Brand Name: VSI Radial™ introducer sheath
• Primary DI: M20690220
• Version / Model: 9022
• Company Name: Vascular Solutions, Inc.
• Labeler DUNS: 008999906
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-05
• Public Version: 5
• Public Version Date: 2019-07-23
• Public Version Status: Update
• Public Device Record Key: 547d51c5-dabd-465e-84f2-cf3e2b375678
• Distribution End Date: 2019-06-30

Device Description

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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DYB	Introducer, Catheter	Cardiovascular	870.1340	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58865	Vascular catheter introduction set, nonimplantable	A collection of sterile, nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator, and typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M20690220	HIBCC
Package	M20690221	HIBCC	Box	5	Not in Commercial Distribution	2019-06-30

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K140768	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Standard Kit
Needle Gauge	21	Gauge
Catheter Gauge	4	French