Wirion

Basic Information

• Brand Name: Wirion
• Primary DI: 10850000491882
• Version / Model: WRN-D6
• Catalog Number: 7-10078-01
• Company Name: Cardiovascular Systems, Inc.
• Labeler DUNS: 024954518
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-03-05
• Public Version: 1
• Public Version Date: 2021-03-15
• Public Version Status: New
• Public Device Record Key: fe93c6bc-9932-4284-93e9-139fd395b56a

Device Description

Wirion Embolic Protection System

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: Yes
• 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
NTE	Temporary Carotid Catheter For Embolic Capture	Cardiovascular	870.1250	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44841	Embolic protection filtering guidewire	A steerable wire with a filter at its distal end intended to be used to facilitate the placement of diagnostic/interventional vascular devices (e.g., angioplasty balloons, intravascular stents) in the lumen of a blood vessel (coronary, carotid, peripheral), and to provide embolic protection by capturing emboli that may result from the procedure. The filter is deployable (expandable) once inserted distal to the vascular lesion (e.g., atherosclerotic plaque). It typically includes devices for introduction/removal of the guidewire (e.g., deployment/removal sheath), which are not intended to be used as working channels for other interventional devices. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10850000491882	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K210282	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Deployed Filter Unit Length 22.5 mm
Device Size Text, specify			Deployed Filter Diameter 3.5-6.0 mm
Device Size Text, specify			Distal tip to strain relief (usable length) - delivery 144 cm
Device Size Text, specify			Rapid Exchange (RX) length - delivery 38 cm
Device Size Text, specify			Maximum catheter diameter - delivery 1.14 mm
Device Size Text, specify			Distal tip to strain relief (usable length) - retrieval 145 cm
Device Size Text, specify			Rapid Exchange (RX) length - retrieval 31 cm
Device Size Text, specify			Maximum catheter diameter - retrieval 1.67 mm