Wirion Delivery Catheter

Basic Information

• Brand Name: Wirion Delivery Catheter
• Primary DI: 72900155120202
• Version / Model: P2-9-0701
• Catalog Number: P2-9-0701
• Company Name: GARDIA MEDICAL LTD
• Labeler DUNS: 531908965
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-11
• Public Version: 5
• Public Version Date: 2019-04-09
• Public Version Status: Update
• Public Device Record Key: 715d1263-f201-443d-9338-57e4e116b12a
• Distribution End Date: 2018-07-16

Device Description

The Wirion Delivery Catheter is supplied as part of the Wirion System Kit, DI 72900155120105 Delivery Catheter: Contains and delivers a Filter Unit, locks it onto the guide wire using the Activating Handle and deploys it in the target vessel (Fig. 1). The Filter Unit is made of a filter membrane and a Nitinol frame. A 5cc syringe with a soft needle is supplied for flushing the system prior to use.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• 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
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	72900155120202	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K143570	000