SurVeil DCB

Device typePeripheral angioplasty balloon catheter, drug-coated: A sterile, flexible tube designed for percutaneous transluminal angioplasty (PTA) to dilate a stenotic peripheral (i.e., non-cerebral, non-coronary) artery by controlled inflation of a distensible balloon(s) at its distal tip, and to simultaneously release a drug intended to inhibit restenosis; it may also be intended for positioning and expansion of a stent/stent-graft. It is available as an over-the-wire (OTW) type with multiple lumens, or a rapid exchange (RX) type with a single-lumen. This is a single-use device.

FDA categoryDrug-Eluting Peripheral Transluminal Angioplasty Catheter

Device ID00812339030548

AvailabilityPrescription

Single useYes

SterileYes

MRI safetyLabeling does not contain MRI Safety Information

Balloon Diameter7 Millimeter

Balloon Length100 Millimeter

Catheter Length135 Centimeter