PRIORITYONE Aspiration Catheter
PRIORITYONE - UG1652
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
- Fragile. Keep dry. Keep away from sunlight.
Device Sizes
- Length: 140 Centimeter
- Min. Guide Catheter I.D. 2.03Millimeter
- Min. Guide Catheter I.D. 0.080Inch
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: DXE
Device Name: Catheter, Embolectomy
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: 870.5150
Third Party Flag: Y
Medical Specialty: CV
Device IdentifiersDevice Id: 74543334177260
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 54543334177266
Package Quantity: 2
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: Carton
Device Id: 54543334177266
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 14543334177268
Package Quantity: 5
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: Carton
Device Id: 04543334177261
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
Device Id: 14543334177268
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 04543334177261
Package Quantity: 1
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: Unit Box