Wirion Delivery Catheter P2-9-0701

GUDID 07290015512022

The Wirion Delivery Catheter is supplied as part of the Wirion System Kit, DI 7290015512015 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. 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.

GARDIA MEDICAL LTD

Embolic protection filtering guidewire

• Primary Device ID: 07290015512022
• NIH Device Record Key: 8bab5535-7066-47be-bb32-6b068ecefa06
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Wirion Delivery Catheter
• Version Model Number: P2-9-0701
• Catalog Number: P2-9-0701
• Company DUNS: 531908965
• Company Name: GARDIA MEDICAL LTD
• 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: +97246277166
• Email: eitan@allium-medical.com
• Phone: +97246277166
• Email: eitan@allium-medical.com
• Phone: +97246277166
• Email: eitan@allium-medical.com
• Phone: +97246277166
• Email: eitan@allium-medical.com
• Phone: +97246277166
• Email: eitan@allium-medical.com
• Phone: +97246277166
• Email: eitan@allium-medical.com
• Phone: +97246277166
• Email: eitan@allium-medical.com
• Phone: +97246277166
• Email: eitan@allium-medical.com
• Phone: +97246277166
• Email: eitan@allium-medical.com
• Phone: +97246277166
• Email: eitan@allium-medical.com
• Phone: +97246277166
• Email: eitan@allium-medical.com
• Phone: +97246277166
• Email: eitan@allium-medical.com
• Phone: +97246277166
• Email: eitan@allium-medical.com
• Phone: +97246277166
• Email: eitan@allium-medical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290015512022 [Primary]
GS1	72900155120202 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143570

FDA Product Code

• NTE: Temporary Carotid Catheter For Embolic Capture

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: 2019-04-09
• Device Publish Date: 2017-02-12

On-Brand Devices [Wirion Delivery Catheter]

• 07290015512022: The Wirion Delivery Catheter is supplied as part of the Wirion System Kit, DI 7290015512015 Deli
• 72900155120202: The Wirion Delivery Catheter is supplied as part of the Wirion System Kit, DI 72900155120105 Del