Control 6F Mechanical Thrombectomy System 135cm

Basic Information

• Brand Name: Control 6F Mechanical Thrombectomy System 135cm
• Primary DI: B090A61350
• Version / Model: A6-135
• Catalog Number: A6-135
• Company Name: ZIEN MEDICAL TECHNOLOGIES, INC.
• Labeler DUNS: 017535668
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-08-17
• Public Version: 8
• Public Version Date: 2024-05-31
• Public Version Status: Update
• Public Device Record Key: 5721e9d1-d3ae-4d87-81f4-5323f1e1ba3a

Device Description

The Control 5-6F Mechanical Thrombectomy System is indicated for the removal of fresh, soft emboli and thrombi from vessels in the peripheral vasculature.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QEZ	Aspiration Thrombectomy Catheter	Cardiovascular	870.5150	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47017	General-purpose syringe, single-use	A sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used for injection/withdrawal of fluids/gas (e.g., medication) to/from a medical device or the body (i.e., capable of both); a needle is not included. It is intended for various medical applications and is not dedicated to medication administration. At the distal end of the barrel is a male connector (typically Luer-lock/slip type) for the attachment to a hypodermic needle or an administration set. It is typically made of plastic and silicone materials and may have anti-stick plunger allowing smooth plunger movement, either manually or by a syringe pump. This is a single-use device.	No	Active
58173	Thrombectomy suction catheter	A flexible or semi-flexible tube designed for the percutaneous, transluminal disruption and removal of clotted blood (i.e., a thrombus or thromboembolus) or other formed elements causing vascular obstruction in native/stented blood vessels, native/synthetic bypass grafts, and/or haemodialysis access grafts, through suction (aspiration) in conjunction with a syringe or dedicated suction pump system (pump not included). It may additionally be intended for infusion of fluids and/or used as a guide-catheter to facilitate introduction of a thrombectomy wire-net (not included) to remove residual thrombus. Collection containers may be included with the catheter. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	B090A61352	HIBCC	Shipper	9	In Commercial Distribution
Package	B090A61351	HIBCC	Shelf Carton	1	In Commercial Distribution
Primary	B090A61350	HIBCC