44b95860-9ded-4d6c-a6d8-0c4470f55069UpdatePublished52023-06-092016-09-052017-01-31Not in Commercial DistributionM20677191PrimaryHIBCCVascular Solutions Custom Access Kit7719008999906Vascular Solutions, Inc.1The Custom Access Kit is intended to introduce up to a 0.038”/0.89mm guidewire or catheter into the vascular system following a needle stick.falsefalsefalsetruefalsetruetruefalsefalsetruefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse888-240-6001customerservice@vasc.com47535Varicose vein lasing procedure kitA collection of sterile devices and materials designed to perform percutaneous laser treatment of varicose veins and varicosities associated with reflux in the superficial veins of the leg. It typically contains an entry needle, a laser fibre, an introducer sheath, a catheter, a guidewire, a dilator, and connectors to facilitate connection to a laser (e.g., a diode laser) and provide a pathway for the laser energy into the section(s) of the vein to be treated. This device does not contain pharmaceuticals. This is a single-use device.falseActiveGEXPowered Laser Surgical InstrumentNeedle GaugeCatheter Gaugetruefalse