FlowTriever Catheter, S

GUDID 00850291007000

FlowTriever Catheter, S

INARI MEDICAL INC

Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter Thrombectomy suction catheter

• Primary Device ID: 00850291007000
• NIH Device Record Key: ada26eaf-fc84-4391-b1e9-cb31df05f2f3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FlowTriever Catheter, S
• Version Model Number: 10-101
• 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

Device Dimensions

• Outer Diameter: 10 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 10 Millimeter
• Outer Diameter: 10 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850291007000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143563

FDA Product Code

• DXE: Catheter, Embolectomy
• QEW: Peripheral Mechanical Thrombectomy With Aspiration

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

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• 00850291007406 - VenaCore Thrombectomy Catheter: 2024-04-04 VenaCore Thrombectomy Catheter
• 00810123710058 - ClotTriever Sheath, 13 Fr: 2023-12-25 ClotTriever Sheath, 13 Fr (ClotTriever Thrombectomy System)
• 00810123710430 - ClotTriever Sheath, 16 Fr: 2023-12-25 ClotTriever Sheath, 16 Fr (ClotTriever Thrombectomy System)
• 00810123710522 - Triever20 Curve: 2023-12-25 Triever20 Curve
• 00850291007420 - FlowStasis Single-Pack: 2023-07-27 FlowStasis Single-Pack
• 00850291007369 - InThrill Sheath: 2023-07-26 InThrill Sheath (InThrill Thrombectomy System)