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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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OTW TAKERU - 04540778168978

OTW TAKERU is a Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Dilatation Catheter for coronary indications. OTW TAKERU is an over the wire (OTW) type and the maximum diameter of the compatible guidewire is 0.014 inches (0.36 mm).
KANEKA CORPORATION
DC-PY1512UA1
In Commercial Distribution

  • 04540778168978 ()

  • Maximum Guidewire Diameter; 0.014 inch
  • Compatible Guiding Catheter; 5 Fr
  • Rated Burst Pressure; 14 atm
  • Nominal Pressure; 6 atm
  • Proximal Shaft Diameter; 3.3 Fr
  • Distal Shaft Diameter; 2.5 Fr
  • Catheter Working Length; 1450 mm
  • Balloon Length; 12 mm
  • Balloon Diameter; 1.5 mm
DC-PY1512UA1

  • Coronary angioplasty balloon catheter, basic

OTW TAKERU - 04540778168954

OTW TAKERU is a Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Dilatation Catheter for coronary indications. OTW TAKERU is an over the wire (OTW) type and the maximum diameter of the compatible guidewire is 0.014 inches (0.36 mm).
KANEKA CORPORATION
DC-PY4010UA2
In Commercial Distribution

  • 04540778168954 ()

  • Maximum Guidewire Diameter; 0.014 inch
  • Compatible Guiding Catheter; 5 Fr
  • Rated Burst Pressure; 14 atm
  • Nominal Pressure; 6 atm
  • Proximal Shaft Diameter; 3.8 Fr
  • Distal Shaft Diameter; 2.8 Fr
  • Catheter Working Length; 1450 mm
  • Balloon Length; 10 mm
  • Balloon Diameter; 4.0 mm
DC-PY4010UA2

  • Coronary angioplasty balloon catheter, basic

OTW TAKERU - 04540778168930

OTW TAKERU is a Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Dilatation Catheter for coronary indications. OTW TAKERU is an over the wire (OTW) type and the maximum diameter of the compatible guidewire is 0.014 inches (0.36 mm).
KANEKA CORPORATION
DC-PY3510UA2
In Commercial Distribution

  • 04540778168930 ()

  • Maximum Guidewire Diameter; 0.014 inch
  • Compatible Guiding Catheter; 5 Fr
  • Rated Burst Pressure; 14 atm
  • Nominal Pressure; 6 atm
  • Proximal Shaft Diameter; 3.3 Fr
  • Distal Shaft Diameter; 2.7 Fr
  • Catheter Working Length; 1450 mm
  • Balloon Length; 10 mm
  • Balloon Diameter; 3.5 mm
DC-PY3510UA2

  • Coronary angioplasty balloon catheter, basic

OTW TAKERU - 04540778168916

OTW TAKERU is a Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Dilatation Catheter for coronary indications. OTW TAKERU is an over the wire (OTW) type and the maximum diameter of the compatible guidewire is 0.014 inches (0.36 mm).
KANEKA CORPORATION
DC-PY3010UA2
In Commercial Distribution

  • 04540778168916 ()

  • Maximum Guidewire Diameter; 0.014 inch
  • Compatible Guiding Catheter; 5 Fr
  • Rated Burst Pressure; 14 atm
  • Nominal Pressure; 6 atm
  • Proximal Shaft Diameter; 3.3 Fr
  • Distal Shaft Diameter; 2.7 Fr
  • Catheter Working Length; 1450 mm
  • Balloon Length; 10 mm
  • Balloon Diameter; 3.0 mm
DC-PY3010UA2

  • Coronary angioplasty balloon catheter, basic

OTW TAKERU - 04540778168893

OTW TAKERU is a Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Dilatation Catheter for coronary indications. OTW TAKERU is an over the wire (OTW) type and the maximum diameter of the compatible guidewire is 0.014 inches (0.36 mm).
KANEKA CORPORATION
DC-PY2510UA2
In Commercial Distribution

  • 04540778168893 ()

  • Maximum Guidewire Diameter; 0.014 inch
  • Compatible Guiding Catheter; 5 Fr
  • Rated Burst Pressure; 14 atm
  • Nominal Pressure; 6 atm
  • Proximal Shaft Diameter; 3.3 Fr
  • Distal Shaft Diameter; 2.7 Fr
  • Catheter Working Length; 1450 mm
  • Balloon Length; 10 mm
  • Balloon Diameter; 2.5 mm
DC-PY2510UA2

  • Coronary angioplasty balloon catheter, basic

OTW TAKERU - 04540778168879

OTW TAKERU is a Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Dilatation Catheter for coronary indications. OTW TAKERU is an over the wire (OTW) type and the maximum diameter of the compatible guidewire is 0.014 inches (0.36 mm).
KANEKA CORPORATION
DC-PY2010UA2
In Commercial Distribution

  • 04540778168879 ()

  • Maximum Guidewire Diameter; 0.014 inch
  • Compatible Guiding Catheter; 5 Fr
  • Rated Burst Pressure; 14 atm
  • Nominal Pressure; 6 atm
  • Proximal Shaft Diameter; 3.3 Fr
  • Distal Shaft Diameter; 2.7 Fr
  • Catheter Working Length; 1450 mm
  • Balloon Length; 10 mm
  • Balloon Diameter; 2.0 mm
DC-PY2010UA2

  • Coronary angioplasty balloon catheter, basic

OTW TAKERU - 04540778168855

OTW TAKERU is a Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Dilatation Catheter for coronary indications. OTW TAKERU is an over the wire (OTW) type and the maximum diameter of the compatible guidewire is 0.014 inches (0.36 mm).
KANEKA CORPORATION
DC-PY1510UA1
In Commercial Distribution

  • 04540778168855 ()

  • Maximum Guidewire Diameter; 0.014 inch
  • Compatible Guiding Catheter; 5 Fr
  • Rated Burst Pressure; 14 atm
  • Nominal Pressure; 6 atm
  • Proximal Shaft Diameter; 3.3 Fr
  • Distal Shaft Diameter; 2.5 Fr
  • Catheter Working Length; 1450 mm
  • Balloon Length; 10 mm
  • Balloon Diameter; 1.5 mm
DC-PY1510UA1

  • Coronary angioplasty balloon catheter, basic

OTW TAKERU - 04540778168831

OTW TAKERU is a Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Dilatation Catheter for coronary indications. OTW TAKERU is an over the wire (OTW) type and the maximum diameter of the compatible guidewire is 0.014 inches (0.36 mm).
KANEKA CORPORATION
DC-PY5008UA2
In Commercial Distribution

  • 04540778168831 ()

  • Maximum Guidewire Diameter; 0.014 inch
  • Compatible Guiding Catheter; 6 Fr
  • Rated Burst Pressure; 14 atm
  • Nominal Pressure; 6 atm
  • Proximal Shaft Diameter; 3.8 Fr
  • Distal Shaft Diameter; 2.8 Fr
  • Catheter Working Length; 1450 mm
  • Balloon Length; 8 mm
  • Balloon Diameter; 5.0 mm
DC-PY5008UA2

  • Coronary angioplasty balloon catheter, basic

OTW TAKERU - 04540778168817

OTW TAKERU is a Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Dilatation Catheter for coronary indications. OTW TAKERU is an over the wire (OTW) type and the maximum diameter of the compatible guidewire is 0.014 inches (0.36 mm).
KANEKA CORPORATION
DC-PY4508UA2
In Commercial Distribution

  • 04540778168817 ()

  • Maximum Guidewire Diameter; 0.014 inch
  • Compatible Guiding Catheter; 6 Fr
  • Rated Burst Pressure; 14 atm
  • Nominal Pressure; 6 atm
  • Proximal Shaft Diameter; 3.8 Fr
  • Distal Shaft Diameter; 2.8 Fr
  • Catheter Working Length; 1450 mm
  • Balloon Length; 8 mm
  • Balloon Diameter; 4.5 mm
DC-PY4508UA2

  • Coronary angioplasty balloon catheter, basic

OTW TAKERU - 04540778168794

OTW TAKERU is a Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Dilatation Catheter for coronary indications. OTW TAKERU is an over the wire (OTW) type and the maximum diameter of the compatible guidewire is 0.014 inches (0.36 mm).
KANEKA CORPORATION
DC-PY4008UA2
In Commercial Distribution

  • 04540778168794 ()

  • Maximum Guidewire Diameter; 0.014 inch
  • Compatible Guiding Catheter; 5 Fr
  • Rated Burst Pressure; 14 atm
  • Nominal Pressure; 6 atm
  • Proximal Shaft Diameter; 3.8 Fr
  • Distal Shaft Diameter; 2.8 Fr
  • Catheter Working Length; 1450 mm
  • Balloon Length; 8 mm
  • Balloon Diameter; 4.0 mm
DC-PY4008UA2

  • Coronary angioplasty balloon catheter, basic
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