FlowTriever Catheter, XL

GUDID 00850291007055

FlowTriever Catheter, 25 mm

INARI MEDICAL INC

Thrombectomy suction catheter

• Primary Device ID: 00850291007055
• NIH Device Record Key: 78ae7863-90a4-4c1c-ab52-883fc4d5bc64
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FlowTriever Catheter, XL
• Version Model Number: 10-104
• Company DUNS: 076827459
• Company Name: INARI MEDICAL 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: 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: 19496008433
• Email: info@inarimedical.com
• Phone: 19496008433
• Email: info@inarimedical.com
• Phone: 19496008433
• Email: info@inarimedical.com
• Phone: 19496008433
• Email: info@inarimedical.com
• Phone: 19496008433
• Email: info@inarimedical.com
• Phone: 19496008433
• Email: info@inarimedical.com
• Phone: 19496008433
• Email: info@inarimedical.com
• Phone: 19496008433
• Email: info@inarimedical.com
• Phone: 19496008433
• Email: info@inarimedical.com
• Phone: 19496008433
• Email: info@inarimedical.com
• Phone: 19496008433
• Email: info@inarimedical.com
• Phone: 19496008433
• Email: info@inarimedical.com
• Phone: 19496008433
• Email: info@inarimedical.com
• Phone: 19496008433
• Email: info@inarimedical.com
• Phone: 19496008433
• Email: info@inarimedical.com
• Phone: 19496008433
• Email: info@inarimedical.com
• Phone: 19496008433
• Email: info@inarimedical.com
• Phone: 19496008433
• Email: info@inarimedical.com
• Phone: 19496008433
• Email: info@inarimedical.com
• Phone: 19496008433
• Email: info@inarimedical.com
• Phone: 19496008433
• Email: info@inarimedical.com
• Phone: 19496008433
• Email: info@inarimedical.com
• Phone: 19496008433
• Email: info@inarimedical.com
• Phone: 19496008433
• Email: info@inarimedical.com
• Phone: 19496008433
• Email: info@inarimedical.com
• Phone: 19496008433
• Email: info@inarimedical.com
• Phone: 19496008433
• Email: info@inarimedical.com
• Phone: 19496008433
• Email: info@inarimedical.com
• Phone: 19496008433
• Email: info@inarimedical.com
• Phone: 19496008433
• Email: info@inarimedical.com

Device Dimensions

• Outer Diameter: 25 Millimeter
• Outer Diameter: 25 Millimeter
• Outer Diameter: 14 Millimeter
• Outer Diameter: 25 Millimeter
• Outer Diameter: 14 Millimeter
• Outer Diameter: 25 Millimeter
• Outer Diameter: 14 Millimeter
• Outer Diameter: 25 Millimeter
• Outer Diameter: 14 Millimeter
• Outer Diameter: 25 Millimeter
• Outer Diameter: 14 Millimeter
• Outer Diameter: 25 Millimeter
• Outer Diameter: 14 Millimeter
• Outer Diameter: 25 Millimeter
• Outer Diameter: 14 Millimeter
• Outer Diameter: 25 Millimeter
• Outer Diameter: 14 Millimeter
• Outer Diameter: 25 Millimeter
• Outer Diameter: 14 Millimeter
• Outer Diameter: 25 Millimeter
• Outer Diameter: 14 Millimeter
• Outer Diameter: 25 Millimeter
• Outer Diameter: 14 Millimeter
• Outer Diameter: 25 Millimeter
• Outer Diameter: 14 Millimeter
• Outer Diameter: 25 Millimeter
• Outer Diameter: 14 Millimeter
• Outer Diameter: 25 Millimeter
• Outer Diameter: 14 Millimeter
• Outer Diameter: 25 Millimeter
• Outer Diameter: 14 Millimeter
• Outer Diameter: 25 Millimeter
• Outer Diameter: 14 Millimeter
• Outer Diameter: 25 Millimeter
• Outer Diameter: 14 Millimeter
• Outer Diameter: 25 Millimeter
• Outer Diameter: 14 Millimeter
• Outer Diameter: 25 Millimeter
• Outer Diameter: 14 Millimeter
• Outer Diameter: 25 Millimeter
• Outer Diameter: 14 Millimeter
• Outer Diameter: 25 Millimeter
• Outer Diameter: 14 Millimeter
• Outer Diameter: 25 Millimeter
• Outer Diameter: 14 Millimeter
• Outer Diameter: 25 Millimeter
• Outer Diameter: 14 Millimeter
• Outer Diameter: 25 Millimeter
• Outer Diameter: 14 Millimeter
• Outer Diameter: 25 Millimeter
• Outer Diameter: 14 Millimeter
• Outer Diameter: 25 Millimeter
• Outer Diameter: 14 Millimeter
• Outer Diameter: 25 Millimeter
• Outer Diameter: 14 Millimeter
• Outer Diameter: 25 Millimeter
• Outer Diameter: 14 Millimeter
• Outer Diameter: 25 Millimeter
• Outer Diameter: 14 Millimeter
• Outer Diameter: 25 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850291007055 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143563

FDA Product Code

• DXE: Catheter, Embolectomy

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: 2020-02-04
• Device Publish Date: 2016-09-15

Devices Manufactured by INARI MEDICAL INC

• 00810123710577 - Artix Thin-Walled Sheath: 2024-11-19 Artix Thin-Walled Sheath
• 00810123710584 - Artix MT: 2024-11-19 Artix MT (Thrombectomy Device)
• 00810123710591 - Artix MT: 2024-11-19 Artix MT (Thrombectomy Device)
• 00810123710560 - Artix Thin-Walled Sheath: 2024-11-15 Artix Thin-Walled Sheath (Thrombectomy Sheath)
• 00810123710478 - 16 Fr Evacuation System: 2024-10-18 16 Fr Evacuation System
• 00810123710485 - 24 Fr Evacuation System: 2024-10-18 24 Fr Evacuation System
• 00810123710546 - FlowSaver: 2024-06-06 FlowSaver
• 00810123710096 - Triever24: 2024-04-25