dfcb0149-2288-4fae-bae3-039c60d20b5fUpdatePublished42019-03-212016-07-30In Commercial Distribution00814548012575PrimaryGS1PX SLIM Delivery MicrocatheterPXSLIM160130-A191077671PENUMBRA, INC.1AdvPX400 J 160DualMBfalsefalsefalsefalsefalsetruetruetruefalsetruefalsefalsetrueLabeling does not contain MRI Safety InformationfalsefalseK10082600010691Vascular microcatheterA sterile, small-diameter, single-lumen, flexible tube designed for the controlled infusion of fluids (e.g., thrombolytics, diagnostic contrast media) into superselective small vessels (including intracranial, peripheral, or occluded coronary vasculature) for angiography/treatment, and typically also for the delivery of devices (e.g., embolization implants, guidewires) into tortuous vessels or across tight lesions. It may include an ultrasound transducer, a thermal sensor, and a hole for guidewire placement located at the distal tip. It is not a guide-catheter (i.e., is not intended to deliver other catheters or therapeutic leads directly through its lumen). This is a single-use device.falseActiveDQYCATHETER, PERCUTANEOUStruefalse