Control RX-LP Mechanical Thrombectomy System ASP-1001

GUDID B090ASP10011

The Control RX-LP6 Mechanical Thrombectomy Catheter™ and the Control Medical Mechanical Aspirator™ are indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature.

ZIEN MEDICAL TECHNOLOGIES, INC.

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• Primary Device ID: B090ASP10011
• NIH Device Record Key: 5ea14b29-465c-4000-893b-9cd0e2df093f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Control RX-LP Mechanical Thrombectomy System
• Version Model Number: ASP-1001
• Catalog Number: ASP-1001
• 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 Gauge: 6 French
• Catheter Length: 136 Centimeter
• Catheter Gauge: 6 French
• Catheter Length: 136 Centimeter
• Catheter Gauge: 6 French
• Catheter Length: 136 Centimeter
• Catheter Gauge: 6 French
• Catheter Length: 136 Centimeter
• Catheter Gauge: 6 French
• Catheter Length: 136 Centimeter
• Catheter Gauge: 6 French
• Catheter Length: 136 Centimeter
• Catheter Gauge: 6 French
• Catheter Length: 136 Centimeter
• Catheter Gauge: 6 French
• Catheter Length: 136 Centimeter
• Catheter Gauge: 6 French
• Catheter Length: 136 Centimeter
• Catheter Gauge: 6 French
• Catheter Length: 136 Centimeter
• Catheter Gauge: 6 French
• Catheter Length: 136 Centimeter
• Catheter Gauge: 6 French
• Catheter Length: 136 Centimeter
• Catheter Gauge: 6 French
• Catheter Length: 136 Centimeter
• Catheter Gauge: 6 French
• Catheter Length: 136 Centimeter
• Catheter Gauge: 6 French
• Catheter Length: 136 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B090ASP10010 [Primary]
HIBCC	B090ASP10011 [Package]; Contains: B090ASP10010; Package: Shelf Carton [1 Units]; In Commercial Distribution
HIBCC	B090ASP10012 [Package]; Package: Shipper Box [9 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131998

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: 2023-05-04
• Device Publish Date: 2023-04-26

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