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Drug-coated balloons

LUTONIX Drug Coated Balloon

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 Drug Coated Balloon models and sizes

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

Model / catalog no.SizeMRIStatus
BSCLX3575460— Not statedAvailable
BSCLX3575560— Not statedAvailable
BSCLX3575580— Not statedAvailable
BSCLX3575660— Not statedAvailable
BSCLX3575680— Not statedAvailable
BSCLX3575740— Not statedAvailable
BSCLX3575760— Not statedAvailable
BSCLX35130440— Not statedAvailable
BSCLX35130460— Not statedAvailable
BSCLX35130480— Not statedAvailable
BSCLX35130540— Not statedAvailable
BSCLX35130560— Not statedAvailable
BSCLX35130580— Not statedAvailable
BSCLX35130640— Not statedAvailable
BSCLX35130660— Not statedAvailable
BSCLX35130680— Not statedAvailable
BSCLX35130740— Not statedAvailable
BSCLX35130760— Not statedAvailable
BSCLX35754100— Not statedAvailable
BSCLX35754120— Not statedAvailable
BSCLX35754150— Not statedAvailable
BSCLX35755100— Not statedAvailable
BSCLX35755120— Not statedAvailable
BSCLX35755150— Not statedAvailable
BSCLX35756100— Not statedAvailable
BSCLX35756120— Not statedAvailable
BSCLX35756150— Not statedAvailable
BSCLX351304100— Not statedAvailable
BSCLX351304120— Not statedAvailable
BSCLX351304150— Not statedAvailable
BSCLX351305100— Not statedAvailable
BSCLX351305120— Not statedAvailable
BSCLX351306100— Not statedAvailable
BSCLX351306120— Not statedAvailable
BSCLX351306150— Not statedAvailable
BSLX35754405F— Not statedAvailable
BSLX35754605F— Not statedAvailable
BSLX35754805F— Not statedAvailable
BSLX35755405F— Not statedAvailable
BSLX35755605F— Not statedAvailable
BSLX35755805F— Not statedAvailable
BSLX35756405F— Not statedAvailable
BSLX35756605F— Not statedAvailable
BSLX35756805F— Not statedAvailable
BSLX35757405F— Not statedAvailable
BSLX35757605F— Not statedAvailable
BSLX351304405F— Not statedAvailable
BSLX351304605F— Not statedAvailable
BSLX351304805F— Not statedAvailable
BSLX351305405F— Not statedAvailable
BSLX351305605F— Not statedAvailable
BSLX351305805F— Not statedAvailable
BSLX351306405F— Not statedAvailable
BSLX351306605F— Not statedAvailable
BSLX351306805F— Not statedAvailable
BSLX351307405F— Not statedAvailable
BSLX351307605F— Not statedAvailable
BSLX357541005F— Not statedAvailable
BSLX357541205F— Not statedAvailable
BSLX357541505F— Not statedAvailable
BSLX357551005F— Not statedAvailable
BSLX357551205F— Not statedAvailable
BSLX357551505F— Not statedAvailable
BSLX357561005F— Not statedAvailable
BSLX357561205F— Not statedAvailable
BSLX357561505F— Not statedAvailable
BSLX3513041005F— Not statedAvailable
BSLX3513041205F— Not statedAvailable
BSLX3513041505F— Not statedAvailable
BSLX3513051005F— Not statedAvailable
BSLX3513051205F— Not statedAvailable
BSLX3513051505F— Not statedAvailable
BSLX3513061005F— Not statedAvailable
BSLX3513061205F— Not statedAvailable
BSLX3513061505F— Not statedAvailable
LX3540780V— Not statedAvailable
LX3575440— Not statedAvailable
LX3575460— Not statedAvailable
LX3575480— Not statedAvailable
LX3575540— Not statedAvailable
LX3575560— Not statedAvailable
LX3575580— Not statedAvailable
LX3575640— Not statedAvailable
LX3575660— Not statedAvailable
LX3575680— Not statedAvailable
LX3575740— Not statedAvailable
LX3575760— Not statedAvailable
LX3575780VBalloon Length 80 mm Not statedAvailable
LX18754404F— Not statedAvailable
LX18754604F— Not statedAvailable
LX18754804F— Not statedAvailable
LX18755405F— Not statedAvailable
LX18755605F— Not statedAvailable
LX18755805F— Not statedAvailable
LX18756405F— Not statedAvailable
LX18756605F— Not statedAvailable
LX18756805F— Not statedAvailable
LX18757405F— Not statedAvailable
LX18757605F— Not statedAvailable
LX18757805F— Not statedAvailable
LX35100440— Not statedAvailable
LX35100460— Not statedAvailable
LX35100480— Not statedAvailable
LX35100540— Not statedAvailable
LX35100560— Not statedAvailable
LX35100580— Not statedAvailable
LX35100640— Not statedAvailable
LX35100660— Not statedAvailable
LX35100680— Not statedAvailable
LX35100740— Not statedAvailable
LX35100760— Not statedAvailable
LX35100780V— Not statedAvailable
LX35130440— Not statedAvailable
LX35130460— Not statedAvailable
LX35130480— Not statedAvailable
LX35130540— Not statedAvailable
LX35130560— Not statedAvailable
LX35130580— Not statedAvailable
LX35130640— Not statedAvailable
LX35130660— Not statedAvailable
LX35130680— Not statedAvailable
LX35130740— Not statedAvailable
LX35130760— Not statedAvailable
LX35130780— Not statedAvailable
LX35401260V— Not statedAvailable
LX35407100V— Not statedAvailable
LX35754100— Not statedAvailable
LX35754120— Not statedAvailable
LX35754150— Not statedAvailable
LX35754405F— Not statedAvailable
LX35754605F— Not statedAvailable
LX35754805F— Not statedAvailable
LX35755100— Not statedAvailable
LX35755120— Not statedAvailable
LX35755150— Not statedAvailable
LX35755405F— Not statedAvailable
LX35755605F— Not statedAvailable
LX35755805F— Not statedAvailable
LX35756100— Not statedAvailable
LX35756120— Not statedAvailable
LX35756150— Not statedAvailable
LX35756405F— Not statedAvailable
LX35756605F— Not statedAvailable
LX35756805F— Not statedAvailable
LX35757100VBalloon Length 100 mm Not statedAvailable
LX35757405F— Not statedAvailable
LX35757605F— Not statedAvailable
LX181004404FLength 100 cm; Balloon Length 40 mm Not statedAvailable
LX181004604FLength 100 cm; Balloon Length 60 mm Not statedAvailable
LX181004804FLength 100 cm; Balloon Length 80 mm Not statedAvailable
LX181005405FLength 100 cm; Balloon Length 40 mm Not statedAvailable
LX181005605FBalloon Length 60 mm; Length 100 cm Not statedAvailable
LX181005805FLength 100 cm; Balloon Length 80 mm Not statedAvailable
LX181006405FLength 100 cm; Balloon Length 40 mm Not statedAvailable
LX181006605FBalloon Length 60 mm; Length 100 cm Not statedAvailable
LX181006805FLength 100 cm; Balloon Length 80 mm Not statedAvailable
LX181007405FLength 100 cm; Balloon Length 40 mm Not statedAvailable
LX181007605FBalloon Length 60 mm; Length 100 cm Not statedAvailable
LX181007805FBalloon Length 80 mm; Length 100 cm Not statedAvailable
LX181304404FBalloon Length 40 mm; Length 130 cm Not statedAvailable
LX181304604FLength 130 cm; Balloon Length 60 mm Not statedAvailable
LX181304804FLength 130 cm; Balloon Length 80 mm Not statedAvailable
LX181305405FLength 130 cm; Balloon Length 40 mm Not statedAvailable
LX181305605FLength 130 cm; Balloon Length 60 mm Not statedAvailable
LX181305805FBalloon Length 80 mm; Length 130 cm Not statedAvailable
LX181306405FLength 130 cm; Balloon Length 40 mm Not statedAvailable
LX181306605FLength 130 cm; Balloon Length 60 mm Not statedAvailable
LX181306805FLength 130 cm; Balloon Length 80 mm Not statedAvailable
LX181307405FBalloon Length 40 mm; Length 130 cm Not statedAvailable
LX181307605FBalloon Length 60 mm; Length 130 cm Not statedAvailable
LX181307805FLength 130 cm; Balloon Length 80 mm Not statedAvailable
LX181504404F— Not statedAvailable
LX181504604F— Not statedAvailable
LX181504804F— Not statedAvailable
LX181505405F— Not statedAvailable
LX181505605F— Not statedAvailable
LX181505805F— Not statedAvailable
LX181506405F— Not statedAvailable
LX181506605F— Not statedAvailable
LX181506805F— Not statedAvailable
LX181507405F— Not statedAvailable
LX181507605F— Not statedAvailable
LX181507805F— Not statedAvailable
LX187541004F— Not statedAvailable
LX187541204F— Not statedAvailable
LX187541504F— Not statedAvailable
LX187542204F— Not statedAvailable
LX187551005F— Not statedAvailable
LX187551205F— Not statedAvailable
LX187551505F— Not statedAvailable
LX187552205F— Not statedAvailable
LX187561005F— Not statedAvailable
LX187561205F— Not statedAvailable
LX187561505F— Not statedAvailable
LX187562205F— Not statedAvailable
LX187571005F— Not statedAvailable
LX187571205F— Not statedAvailable
LX187571505F— Not statedAvailable
LX187572205F— Not statedAvailable
LX351001260V— Not statedAvailable
LX351004100— Not statedAvailable
LX351004120— Not statedAvailable
LX351004150— Not statedAvailable
LX351005100— Not statedAvailable
LX351005120— Not statedAvailable
LX351005150— Not statedAvailable
LX351006100— Not statedAvailable
LX351006120— Not statedAvailable
LX351006150— Not statedAvailable
LX351007100V— Not statedAvailable
LX351304100— Not statedAvailable
LX351304120— Not statedAvailable
LX351304150— Not statedAvailable
LX351304405FLength 130 cm; Balloon Length 40 mm Not statedAvailable
LX351304605FLength 130 cm; Balloon Length 60 mm Not statedAvailable
LX351304805FBalloon Length 80 mm; Length 130 cm Not statedAvailable
LX351305100— Not statedAvailable
LX351305120— Not statedAvailable
LX351305150— Not statedAvailable
LX351305405F— Not statedAvailable
LX351305605F— Not statedAvailable
LX351305805F— Not statedAvailable
LX351306100— Not statedAvailable
LX351306120— Not statedAvailable
LX351306150— Not statedAvailable
LX351306220— Not statedAvailable
LX351306405FLength 130 cm; Balloon Length 40 mm Not statedAvailable
LX351306605F— Not statedAvailable
LX351306805F— Not statedAvailable
LX351307100— Not statedAvailable
LX351307120— Not statedAvailable
LX351307150— Not statedAvailable
LX351307220— Not statedAvailable
LX351307405FBalloon Length 40 mm; Length 130 cm Not statedAvailable
LX351307605FBalloon Length 60 mm; Length 130 cm Not statedAvailable
LX351307805FBalloon Length 80 mm; Length 130 cm Not statedAvailable
LX357541005F— Not statedAvailable
LX357541205F— Not statedAvailable
LX357541505F— Not statedAvailable
LX357551005F— Not statedAvailable
LX357551205F— Not statedAvailable
LX357551505F— Not statedAvailable
LX357561005F— Not statedAvailable
LX357561205F— Not statedAvailable
LX357561505F— Not statedAvailable
LX1810041004FBalloon Length 100 mm; Length 100 cm Not statedAvailable
LX1810041204FLength 100 cm; Balloon Length 120 mm Not statedAvailable
LX1810041504FLength 100 cm; Balloon Length 150 mm Not statedAvailable
LX1810042204FBalloon Length 220 mm; Length 100 cm Not statedAvailable
LX1810043005FBalloon Length 300 mm; Length 100 cm Not statedAvailable

Procedures that use drug-coated balloons

Peripheral Balloon AngioplastyPeripheral Atherectomy

Frequently asked questions

What is LUTONIX Drug Coated Balloon 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 Drug Coated Balloon?

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

What sizes does LUTONIX Drug Coated Balloon come in?

Sizes listed for LUTONIX Drug Coated Balloon: Balloon Length: 40–300 mm; Length: 100–130 cm. Confirm availability with the manufacturer's instructions for use.

Is LUTONIX Drug Coated Balloon MRI safe?

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

Is LUTONIX Drug Coated Balloon FDA cleared?

LUTONIX Drug Coated Balloon 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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