ProVue Retriever

ProVue Retriever
Trevo NXT - 90314

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.

• Stent Length: 41.0 Millimeter
• Stent Outer Diameter: 4.0 Millimeter
• Distal Length: 35.0 Millimeter

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: POL

Device Name: Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment

Device Class: 2

Physical State: The device is delivered into the neurovasculature with an endovascular approach and mechanically removes thrombus from the body and restores blood flow.

Definition: A neurovascular mechanical thrombectomy device for acute ischemic stroke treatment is a prescription device used in the treatment of acute ischemic stroke to improve clinical outcomes. The device is delivered into the neurovasculature with an endovascular approach, mechanically removes thrombus from the body, and restores blood flow in the neurovasculature.

Submission Type ID: 1

Review Panel: NE

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: The device is delivered into the neurovasculature with an endovascular approach and mechanically removes thrombus from the body and restores blood flow.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Neurovasculature

Regulation Number: 882.5600

Third Party Flag: N

Medical Specialty: NE

Code: NRY

Device Name: Catheter, Thrombus Retriever

Device Class: 2

Physical State: N/A

Definition: The device is intended to restore blood flow by removing thrombus/clots in patients experiencing ischemic stroke. The prior clearances in this category have been limited to simply identifying catheter placed in the peripheral, coronary, and neurovasculature. It is felt that this is a unique claim and should not be combined with previously cleared catheters under a general procode.

Submission Type ID: 1

Review Panel: NE

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 870.1250

Third Party Flag: N

Medical Specialty: CV

Device Id: 07613327299946

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A