Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Lutonix® AV Drug Coated Balloon PTA Catheter 4x100x75
LUTONIX, INC.
LX35754100V
In Commercial Distribution

  • 00801741135330 ()

  • Balloon Diameter, 4 millimeter
  • Catheter Length, 75 centimeter
  • Balloon Length, 100 millimeter
LX35754100V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 4x80x75
LUTONIX, INC.
LX3575480V
In Commercial Distribution

  • 00801741135323 ()

  • Catheter Length, 75 centimeter
  • Balloon Diameter, 4 millimeter
  • Balloon Length, 80 millimeter
LX3575480V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 4x60x75
LUTONIX, INC.
LX3575460V
In Commercial Distribution

  • 00801741135316 ()

  • Balloon Diameter, 4 millimeter
  • Catheter Length, 75 centimeter
  • Balloon Length, 60 millimeter
LX3575460V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 4x40x75
LUTONIX, INC.
LX3575440V
In Commercial Distribution

  • 00801741135309 ()

  • Balloon Length, 40 millimeter
  • Catheter Length, 75 centimeter
  • Balloon Diameter, 4 millimeter
LX3575440V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 12x40x40
LUTONIX, INC.
LX35401240V
Not in Commercial Distribution

  • 00801741135293 ()

  • Balloon Length, 40 millimeter
  • Catheter Length, 40 centimeter
  • Balloon Diameter, 12 millimeter
LX35401240V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 12x20x40
LUTONIX, INC.
LX35401220V
In Commercial Distribution

  • 00801741135286 ()

  • Balloon Length, 20 millimeter
  • Balloon Diameter, 12 millimeter
  • Catheter Length, 40 centimeter
LX35401220V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 10x60x40
LUTONIX, INC.
LX35401060V
Not in Commercial Distribution

  • 00801741135279 ()

  • Balloon Diameter, 10 millimeter
  • Balloon Length, 60 millimeter
  • Catheter Length, 40 centimeter
LX35401060V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 10x40x40
LUTONIX, INC.
LX35401040V
Not in Commercial Distribution

  • 00801741135262 ()

  • Catheter Length, 40 centimeter
  • Balloon Length, 40 millimeter
  • Balloon Diameter, 10 millimeter
LX35401040V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 10x20x40
LUTONIX, INC.
LX35401020V
In Commercial Distribution

  • 00801741135255 ()

  • Balloon Length, 20 millimeter
  • Balloon Diameter, 10 millimeter
  • Catheter Length, 40 centimeter
LX35401020V

  • Peripheral angioplasty balloon catheter, drug-coated
Lutonix® AV Drug Coated Balloon PTA Catheter 9x60x40
LUTONIX, INC.
LX3540960V
Not in Commercial Distribution

  • 00801741135248 ()

  • Catheter Length, 40 centimeter
  • Balloon Length, 60 millimeter
  • Balloon Diameter, 9 millimeter
LX3540960V

  • Peripheral angioplasty balloon catheter, drug-coated
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