FLOWMATE® Injector
FLOWMATE® - INJ100
Device Description
A mains electricity (AC-powered) component of a mechanical atherectomy system designed to inject cooled normal sterile saline and/or surgical lubricant via the system’s dedicated catheter into the site of crossing a chronic partial occlusion (CPO) or chronic total occlusion (CTO) in both coronary and peripheral arteries. The device functions as a pump and will typically work in synchronization with the generator, whereby it may also function as the mains adaptor/control unit. This is a reusable device.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: DXT
Device Name: Injector And Syringe, Angiographic
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: HO
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: 870.1650
Third Party Flag: Y
Medical Specialty: CV
Device IdentifiersDevice Id: 00801741067686
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