Intermediate Catheter

Intermediate Catheter
AXS VECTA 46 - INC-11814-153

A flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), needle or guidewire through its lumen(s), within the vascular system. It may be rigid or flexible, non-steerable or steerable, single or multiple lumen(s), and the distal section can have a variety of preformed shapes (e.g., straight, hockey stick). It is not intended solely for infusion, is not intended to access superselective small vessels, and does not include a transseptal needle. It may include a disposable percutaneous introduction set or shaft visualization electrodes. This is a single-use device.

• Lumen/Inner Diameter: 0.046 Inch
• Length: 153.0 Centimeter

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

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: 07613327519372

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