Intermediate Catheter
AXS VECTA 74 - INC-11597-125
Device Description
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.
Environmental Conditions
- Store in cool, dry, dark place.
Device Sizes
- Lumen/Inner Diameter: 0.074 Inch
- Length: 125.0 Centimeter
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
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 IdentifiersDevice Id: 07613327459258
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