Control 11F Mechanical Thrombectomy System A11-090

GUDID B090A110901

The Control 7-11F Mechanical Thrombectomy System and Control Mechanical Aspirator are indicated for the removal of fresh soft emboli and thrombi from vessels in the peripheral vasculature.

ZIEN MEDICAL TECHNOLOGIES, INC.

General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use

• Primary Device ID: B090A110901
• NIH Device Record Key: 41c400dc-af3c-4fda-bd2f-2993428238fb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Control 11F Mechanical Thrombectomy System
• Version Model Number: A11-090
• Catalog Number: A11-090
• Company DUNS: 017535668
• Company Name: ZIEN MEDICAL TECHNOLOGIES, 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

Device Dimensions

• Catheter Working Length: 90 Centimeter
• Catheter Gauge: 11 French
• Catheter Working Length: 90 Centimeter
• Catheter Gauge: 11 French
• Catheter Working Length: 90 Centimeter
• Catheter Gauge: 11 French
• Catheter Working Length: 90 Centimeter
• Catheter Gauge: 11 French
• Catheter Working Length: 90 Centimeter
• Catheter Gauge: 11 French
• Catheter Working Length: 90 Centimeter
• Catheter Gauge: 11 French
• Catheter Working Length: 90 Centimeter
• Catheter Gauge: 11 French
• Catheter Working Length: 90 Centimeter
• Catheter Gauge: 11 French
• Catheter Working Length: 90 Centimeter
• Catheter Gauge: 11 French
• Catheter Working Length: 90 Centimeter
• Catheter Gauge: 11 French
• Catheter Working Length: 90 Centimeter
• Catheter Gauge: 11 French
• Catheter Working Length: 90 Centimeter
• Catheter Gauge: 11 French
• Catheter Working Length: 90 Centimeter
• Catheter Gauge: 11 French
• Catheter Working Length: 90 Centimeter
• Catheter Gauge: 11 French
• Catheter Working Length: 90 Centimeter
• Catheter Gauge: 11 French
• Catheter Working Length: 90 Centimeter
• Catheter Gauge: 11 French
• Catheter Working Length: 90 Centimeter
• Catheter Gauge: 11 French
• Catheter Working Length: 90 Centimeter
• Catheter Gauge: 11 French

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B090A110900 [Primary]
HIBCC	B090A110901 [Package]; Contains: B090A110900; Package: Shelf Carton [1 Units]; In Commercial Distribution
HIBCC	B090A110902 [Package]; Package: Shipper [9 Units]; In Commercial Distribution

FDA Product Code

• QEZ: Aspiration Thrombectomy Catheter

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-07-07
• Device Publish Date: 2022-06-29

On-Brand Devices [Control 11F Mechanical Thrombectomy System]

• B090A110901: The Control 7-11F Mechanical Thrombectomy System and Control Mechanical Aspirator are indicated
• B090ASP10361: The Control 7-11F Mechanical Thrombectomy System and Control Mechanical Aspirator are indicated
• B090ASP10211: The Control 7-11F Mechanical Thrombectomy System and Control Mechanical Aspirator are indicated