Intermediate Catheter

Intermediate Catheter
AXS VECTA 71 - INC-11129-115

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.

• Length: 115.0 Centimeter
• Lumen/Inner Diameter: 0.071 Inch

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: DQY

Device Name: Catheter, Percutaneous

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: CV

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: Y

Medical Specialty: CV

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

Code: QJP

Device Name: Catheter, Percutaneous, Neurovasculature

Device Class: 2

Physical State: Percutaneous catheter for neurovasculature

Definition: To provide vascular access to the neurovasculature for interventional or diagnostic procedures

Submission Type ID: 1

Review Panel: NE

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Uses a catheter to provide access to the neurovasculature for interventional or diagnostic procedures

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Neurovasculature

Regulation Number: 870.1250

Third Party Flag: Y

Medical Specialty: CV

Device Id: 07613327459210

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