JETi All In One Accessory Cart

GUDID B139WVCART2

WALK VASCULAR L.L.C.

Mechanical atherectomy/thrombectomy drive system

• Primary Device ID: B139WVCART2
• NIH Device Record Key: 0a0b5cfd-890e-452d-bc08-7aa1261e49be
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: JETi All In One Accessory Cart
• Version Model Number: WVCART
• Company DUNS: 034774488
• Company Name: WALK VASCULAR L.L.C.
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B139WVCART0 [Primary]
HIBCC	B139WVCART2 [Package]; Contains: B139WVCART0; Package: [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201998

FDA Product Code

• QEZ: Aspiration Thrombectomy Catheter

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-03-08
• Device Publish Date: 2021-02-26

On-Brand Devices [JETi All In One Accessory Cart]

• B139WVCART2: WVCART
• 08717648351372: WVCART