Balloon Applicator

Device typeIntraoperative/postoperative therapeutic x-ray system balloon applicator kit: A sterile collection of devices that is a component of an intraoperative/postoperative therapeutic x-ray system designed for the administration of radiation in certain clinical applications, typically intraoperatively within a resected breast tumour bed. It typically consists of a set of cavity ball gauges used for measurement of the cavity, and a set of graduated size balloon applicators. The required size of applicator is intended to be placed in the tumour cavity after lumpectomy and inflated, and the inner catheter is designed to hold the tube of the x-ray source, stabilized by a probe guard, during radiotherapy treatment. This is a single-use device.

FDA categorySystem, Therapeutic, X-Ray

Device ID00858012005991

Catalog numberAB2071

AvailabilityPrescription

Single useYes

SterileYes

MRI safetyLabeling does not contain MRI Safety Information