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Drug-coated balloons

LUTONIX 035 Drug Coated Balloon PTA Catheter

by Lutonix, Inc.

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.

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LUTONIX 035 Drug Coated Balloon PTA Catheter models and sizes

From the FDA Global Unique Device Identification Database. Confirm with the manufacturer's instructions for use.

Model / catalog no.SizeMRIStatus
LX3540440V— Not statedAvailable
LX3540460V— Not statedAvailable
LX3540480V— Not statedAvailable
LX3540540V— Not statedAvailable
LX3540560V— Not statedAvailable
LX3540580V— Not statedAvailable
LX3540640V— Not statedAvailable
LX3540660V— Not statedAvailable
LX3540680V— Not statedAvailable
LX3540740V— Not statedAvailable
LX3540760V— Not statedAvailable
LX3540820V— Not statedAvailable
LX3540840V— Not statedAvailable
LX3540860V— Not statedAvailable
LX3540920V— Not statedAvailable
LX3540940V— Not statedAvailable
LX3540960V— Not statedAvailable
LX3575440V— Not statedAvailable
LX3575460V— Not statedAvailable
LX3575480V— Not statedAvailable
LX3575540VBalloon Length 40 mm Not statedAvailable
LX3575560VBalloon Length 60 mm Not statedAvailable
LX3575580VBalloon Length 80 mm Not statedAvailable
LX3575640VBalloon Length 40 mm Not statedAvailable
LX3575660VBalloon Length 60 mm Not statedAvailable
LX3575680VBalloon Length 80 mm Not statedAvailable
LX3575740VBalloon Length 40 mm Not statedAvailable
LX3575760VBalloon Length 60 mm Not statedAvailable
LX3575820V— Not statedAvailable
LX3575840V— Not statedAvailable
LX3575860V— Not statedAvailable
LX3575920V— Not statedAvailable
LX3575940V— Not statedAvailable
LX3575960V— Not statedAvailable
LX35100440V— Not statedAvailable
LX35100460V— Not statedAvailable
LX35100480V— Not statedAvailable
LX35100540V— Not statedAvailable
LX35100560V— Not statedAvailable
LX35100580V— Not statedAvailable
LX35100640V— Not statedAvailable
LX35100660V— Not statedAvailable
LX35100680V— Not statedAvailable
LX35100740V— Not statedAvailable
LX35100760V— Not statedAvailable
LX35100820V— Not statedAvailable
LX35100840V— Not statedAvailable
LX35100860V— Not statedAvailable
LX35100920V— Not statedAvailable
LX35100940V— Not statedAvailable
LX35100960V— Not statedAvailable
LX35401020V— Not statedAvailable
LX35401040V— Not statedAvailable
LX35401060V— Not statedAvailable
LX35401220V— Not statedAvailable
LX35401240V— Not statedAvailable
LX35404100V— Not statedAvailable
LX35405100V— Not statedAvailable
LX35406100V— Not statedAvailable
LX35751020V— Not statedAvailable
LX35751040V— Not statedAvailable
LX35751060V— Not statedAvailable
LX35751220V— Not statedAvailable
LX35751240V— Not statedAvailable
LX35751260V— Not statedAvailable
LX35754100VBalloon Length 100 mm Not statedAvailable
LX35755100VBalloon Length 100 mm Not statedAvailable
LX35756100VBalloon Length 100 mm Not statedAvailable
LX351001020V— Not statedAvailable
LX351001040V— Not statedAvailable
LX351001060V— Not statedAvailable
LX351001220V— Not statedAvailable
LX351001240V— Not statedAvailable
LX351004100V— Not statedAvailable
LX351005100V— Not statedAvailable
LX351006100V— Not statedAvailable

Procedures that use drug-coated balloons

Peripheral Balloon AngioplastyPeripheral Atherectomy

Frequently asked questions

What is LUTONIX 035 Drug Coated Balloon PTA Catheter used for?

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.

Who makes LUTONIX 035 Drug Coated Balloon PTA Catheter?

LUTONIX 035 Drug Coated Balloon PTA Catheter is made by Lutonix, Inc.. It is listed under drug-coated balloons in our device library.

What sizes does LUTONIX 035 Drug Coated Balloon PTA Catheter come in?

Sizes listed for LUTONIX 035 Drug Coated Balloon PTA Catheter: Balloon Length: 40–100 mm. Confirm availability with the manufacturer's instructions for use.

Is LUTONIX 035 Drug Coated Balloon PTA Catheter MRI safe?

The FDA device database entry for LUTONIX 035 Drug Coated Balloon PTA Catheter does not state its MRI safety status. Check the labeling before MRI.

Is LUTONIX 035 Drug Coated Balloon PTA Catheter FDA cleared?

LUTONIX 035 Drug Coated Balloon PTA Catheter is registered in the FDA's Global Unique Device Identification Database (GUDID).

How do I contact a Lutonix, Inc. sales representative?

Lutonix, Inc. has not listed representatives on LA Vascular yet. Visit the Lutonix, Inc. company page for contact details.

Models, sizes and MRI status come from the FDA Global Unique Device Identification Database (GUDID); descriptions marked "provided by the manufacturer" are reviewed before publishing. Not an endorsement; follow the manufacturer's instructions for use.

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