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SEISMIQ™

Intravascular Lithotripsy Catheter

Details

Device typeIntravascular lithotripsy system catheter, balloon, peripheral: An electrically-powered, flexible tube, with an inflatable balloon at its distal end, intended to be introduced into a peripheral artery (excludes coronary and cerebral arteries) to transmit ultrasonic acoustic pressure waves circumferentially for the modification and fragmentation of calcified plaque, to improve vessel compliance. It includes transducers intended to convert electrical to ultrasonic energy, and a balloon to facilitate energy transmission and vessel dilation. It is used in conjunction with a dedicated control unit/generator (not included). This is a single-use device.

FDA categoryPercutaneous Catheter, Ultrasound

Device ID00850056723015

Catalog numberFG-006913

AvailabilityPrescription

Single useYes

SterileYes

MRI safetyLabeling does not contain MRI Safety Information

Balloon Diameter4 Millimeter

Balloon Length60 Millimeter

Contact

No contact is listed for this device.

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