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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 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-PY3512UA2
In Commercial Distribution

  • 04540778169111 ()

  • 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; 12 mm
  • Balloon Diameter; 3.5 mm
DC-PY3512UA2

  • Coronary angioplasty balloon catheter, basic
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-PY3212UA2
In Commercial Distribution

  • 04540778169098 ()

  • 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; 12 mm
  • Balloon Diameter; 3.25 mm
DC-PY3212UA2

  • Coronary angioplasty balloon catheter, basic
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-PY3012UA2
In Commercial Distribution

  • 04540778169074 ()

  • 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; 12 mm
  • Balloon Diameter; 3.0 mm
DC-PY3012UA2

  • Coronary angioplasty balloon catheter, basic
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-PY2712UA2
In Commercial Distribution

  • 04540778169050 ()

  • 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; 12 mm
  • Balloon Diameter; 2.75 mm
DC-PY2712UA2

  • Coronary angioplasty balloon catheter, basic
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-PY2512UA2
In Commercial Distribution

  • 04540778169036 ()

  • 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; 12 mm
  • Balloon Diameter; 2.5 mm
DC-PY2512UA2

  • Coronary angioplasty balloon catheter, basic
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-PY2212UA2
In Commercial Distribution

  • 04540778169012 ()

  • 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; 12 mm
  • Balloon Diameter; 2.25 mm
DC-PY2212UA2

  • Coronary angioplasty balloon catheter, basic
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-PY2012UA2
In Commercial Distribution

  • 04540778168992 ()

  • 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; 12 mm
  • Balloon Diameter; 2.0 mm
DC-PY2012UA2

  • Coronary angioplasty balloon catheter, basic
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 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 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
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