Control 7F Mechanical Thrombectomy System A7-060

GUDID B090A70600

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.

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

• Primary Device ID: B090A70600
• NIH Device Record Key: 872f49ac-e6d8-4810-8fff-696fdbcb3989
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Control 7F Mechanical Thrombectomy System
• Version Model Number: A7-060
• Catalog Number: A7-060
• 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: 60 Centimeter
• Catheter Gauge: 7 French
• Catheter Working Length: 60 Centimeter
• Catheter Gauge: 7 French
• Catheter Working Length: 60 Centimeter
• Catheter Gauge: 7 French
• Catheter Working Length: 60 Centimeter
• Catheter Gauge: 7 French
• Catheter Working Length: 60 Centimeter
• Catheter Gauge: 7 French
• Catheter Working Length: 60 Centimeter
• Catheter Gauge: 7 French
• Catheter Working Length: 60 Centimeter
• Catheter Gauge: 7 French
• Catheter Working Length: 60 Centimeter
• Catheter Gauge: 7 French
• Catheter Working Length: 60 Centimeter
• Catheter Gauge: 7 French
• Catheter Working Length: 60 Centimeter
• Catheter Gauge: 7 French
• Catheter Working Length: 60 Centimeter
• Catheter Gauge: 7 French
• Catheter Working Length: 60 Centimeter
• Catheter Gauge: 7 French
• Catheter Working Length: 60 Centimeter
• Catheter Gauge: 7 French
• Catheter Working Length: 60 Centimeter
• Catheter Gauge: 7 French
• Catheter Working Length: 60 Centimeter
• Catheter Gauge: 7 French
• Catheter Working Length: 60 Centimeter
• Catheter Gauge: 7 French
• Catheter Working Length: 60 Centimeter
• Catheter Gauge: 7 French
• Catheter Working Length: 60 Centimeter
• Catheter Gauge: 7 French

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B090A70600 [Primary]
HIBCC	B090A70601 [Package]; Package: Shelf Carton [1 Units]; In Commercial Distribution
HIBCC	B090A70602 [Package]; Contains: B090A70601; 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 7F Mechanical Thrombectomy System]

• B090A70901: The Control 7-11F Mechanical Thrombectomy System and Control Mechanical Aspirator are indicated
• B090A70600: The Control 7-11F Mechanical Thrombectomy System and Control Mechanical Aspirator are indicated
• B090ASP10331: The Control 7-11F Mechanical Thrombectomy System and Control Mechanical Aspirator are indicated
• B090ASP10131: The Control 7-11F Mechanical Thrombectomy System and Control Mechanical Aspirator are indicated