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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® Drug Coated Balloon - 00801741163401

Lutonix 035 DCB, 4mm x 220mm x 130cm, 5F
LUTONIX, INC.
LX3513042205F
In Commercial Distribution

  • 00801741163401 ()

  • Balloon Length, 220 Millimeter
  • Balloon Diameter, 4 Millimeter
  • Catheter Length, 130 Centimeter
LX3513042205F

  • Peripheral angioplasty balloon catheter, drug-coated

SurVeil DCB - 00812339030449

SurVeil DCB 5.0mm x 150mm x 135cm
Surmodics, Inc.
SRV03513505015
In Commercial Distribution

  • 00812339030449 ()

  • Balloon Diameter: 5 Millimeter
  • Balloon Diameter: 150 Millimeter
  • Catheter Length: 135 Centimeter


  • Peripheral angioplasty balloon catheter, drug-coated

AGENT™ - 00191506014902

Paclitaxel-Coated Balloon Catheter
BOSTON SCIENTIFIC CORPORATION
H7493960830350
In Commercial Distribution

  • 00191506014902 ()

  • Balloon Diameter: 3.50 Millimeter
  • Balloon Length: 30 Millimeter
H7493960830350

  • Coronary angioplasty balloon catheter, drug-coated

AGENT™ - 00191506014896

Paclitaxel-Coated Balloon Catheter
BOSTON SCIENTIFIC CORPORATION
H7493960830300
In Commercial Distribution

  • 00191506014896 ()

  • Balloon Length: 30 Millimeter
  • Balloon Diameter: 3 Millimeter
H7493960830300

  • Coronary angioplasty balloon catheter, drug-coated

AGENT™ - 00191506014889

Paclitaxel-Coated Balloon Catheter
BOSTON SCIENTIFIC CORPORATION
H7493960830270
In Commercial Distribution

  • 00191506014889 ()

  • Balloon Length: 30 Millimeter
  • Balloon Diameter: 2.75 Millimeter
H7493960830270

  • Coronary angioplasty balloon catheter, drug-coated

AGENT™ - 00191506014872

Paclitaxel-Coated Balloon Catheter
BOSTON SCIENTIFIC CORPORATION
H7493960830250
In Commercial Distribution

  • 00191506014872 ()

  • Balloon Diameter: 2.50 Millimeter
  • Balloon Length: 30 Millimeter
H7493960830250

  • Coronary angioplasty balloon catheter, drug-coated

AGENT™ - 00191506014865

Paclitaxel-Coated Balloon Catheter
BOSTON SCIENTIFIC CORPORATION
H7493960830220
In Commercial Distribution

  • 00191506014865 ()

  • Balloon Diameter: 2.25 Millimeter
  • Balloon Length: 30 Millimeter
H7493960830220

  • Coronary angioplasty balloon catheter, drug-coated

AGENT™ - 00191506014858

Paclitaxel-Coated Balloon Catheter
BOSTON SCIENTIFIC CORPORATION
H7493960830200
In Commercial Distribution

  • 00191506014858 ()

  • Balloon Diameter: 2 Millimeter
  • Balloon Length: 30 Millimeter
H7493960830200

  • Coronary angioplasty balloon catheter, drug-coated

AGENT™ - 00191506014841

Paclitaxel-Coated Balloon Catheter
BOSTON SCIENTIFIC CORPORATION
H7493960820400
In Commercial Distribution

  • 00191506014841 ()

  • Balloon Length: 20 Millimeter
  • Balloon Diameter: 4 Millimeter
H7493960820400

  • Coronary angioplasty balloon catheter, drug-coated

AGENT™ - 00191506014834

Paclitaxel-Coated Balloon Catheter
BOSTON SCIENTIFIC CORPORATION
H7493960820350
In Commercial Distribution

  • 00191506014834 ()

  • Balloon Diameter: 3.50 Millimeter
  • Balloon Length: 20 Millimeter
H7493960820350

  • Coronary angioplasty balloon catheter, drug-coated
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