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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Endovenous Radiofrequency Ablation (RFA) Catheter 7-60
Vein360 LLC
VEN-7-60
Not in Commercial Distribution

  • 08600360005107 ()
VEN-7-60

  • Radio-frequency ablation system
Endovenous Radiofrequency Ablation (RFA) Catheter 3-60
Vein360 LLC
VEN-3-60
Not in Commercial Distribution

  • 08600360005022 ()
VEN-3-60

  • Radio-frequency ablation system
Endovenous Radiofrequency Ablation (RFA) Catheter 7-100
Vein360 LLC
VEN-7-100
Not in Commercial Distribution

  • 08600360005008 ()
VEN-7-100

  • Radio-frequency ablation system
STEALTH, CLASSIC, 1.50MM, 145CM SHAFT
Cardiovascular Systems, Inc.
DBE-150
In Commercial Distribution

  • 10852528005015 ()

  • Intro Sheath 6 Fr
  • Max OD 0.070 inches
  • high speed 140 krpm
  • medium speed 90 krpm
  • low speed 60 krpm
  • guidewire size OD 0.014 inches
  • shaft length 145 cm
  • nose length 15 mm
  • Crown diameter 1.50 mm
  • Crown Type, Classic
70056-01

  • Mechanical atherectomy system catheter, peripheral
Diamondback Peripheral, Exchangeable Series, Cartridge, 1.25 Micro, 75 cm shaft
Cardiovascular Systems, Inc.
DBP-CART-125MIC75
In Commercial Distribution

  • 10852528005961 ()

  • Intro Sheath: 4 Fr
  • Max OD: 0.052 inches
  • Crown Type: Micro
  • High Speed: 140 krpm
  • Medium Speed: 90 krpm
  • Low Speed: 60 krpm
  • Guidewire: 0.014 inches
  • Shaft Length: 75 cm
  • Nose Length: 7 mm
  • Crown diameter: 1.25 mm
7-10031-05

  • Mechanical atherectomy system catheter, peripheral
Diamondback Peripheral, Exchangeable Series, Cartridge, 2.00 Solid, 145 cm shaft
Cardiovascular Systems, Inc.
DBP-CART-200SOL145
In Commercial Distribution

  • 10852528005954 ()

  • Intro Sheath: 6 Fr
  • Max OD: 0.079 inches
  • Crown Type: Solid
  • High Speed: 120 krpm
  • Medium Speed: 90 krpm
  • Low Speed: 60 krpm
  • Guidewire: 0.014 inches
  • Shaft Length: 145 cm
  • Nose Length: 30 mm
  • Crown Diameter: 2.00 mm
7-10031-04

  • Mechanical atherectomy system catheter, peripheral
Diamondback Peripheral, Exchangeable Series, Cartridge, 1.50 Solid, 145 cm shaft
Cardiovascular Systems, Inc.
DBP-CART-150SOL145
In Commercial Distribution

  • 10852528005947 ()

  • Intro Sheath: 5 Fr
  • Max OD: 0.063 inches
  • Crown Type: Solid
  • High Speed: 120 krpm
  • Medium Speed: 90 krpm
  • Low Speed: 60 krpm
  • Guidewire: 0.014 inches
  • Shaft Length: 145 cm
  • Nose Length: 10 mm
  • Crown Diameter: 1.50 mm
7-10031-03

  • Mechanical atherectomy system catheter, peripheral
Diamondback Peripheral, Exchangeable Series, Cartridge, 1.25 Solid, 145 cm shaft
Cardiovascular Systems, Inc.
DBP-CART-125SOL145
In Commercial Distribution

  • 10852528005930 ()

  • Intro Sheath: 4 Fr
  • Max OD: 0.052 inches
  • Crown Type: Solid
  • High Speed: 120 krpm
  • Medium Speed: 90 krpm
  • Low Speed: 60 krpm
  • Guidewire: 0.014 inches
  • Shaft Length: 145 cm
  • Nose Length: 7 mm
  • Crown Diameter: 1.25 mm
7-10031-02

  • Mechanical atherectomy system catheter, peripheral
Diamondback Peripheral, Exchangeable Series, Cartridge, 1.25 Micro, 145 cm shaft
Cardiovascular Systems, Inc.
DBP-CART-125MIC145
In Commercial Distribution

  • 10852528005923 ()

  • Intro Sheath: 4 Fr
  • Max OD: 0.052 inches
  • Crown Type: Micro
  • High Speed: 140 krpm
  • Medium Speed: 90 krpm
  • Low Speed: 60 krpm
  • Guidewire: 0.014 inches
  • Shaft Length: 145 cm
  • Nose Length: 7 mm
  • Crown Diameter: 1.25 mm
7-10031-01

  • Mechanical atherectomy system catheter, peripheral
Diamondback Peripheral, Exchangeable Series, 2.00 Classic, 145 cm shaft
Cardiovascular Systems, Inc.
DBP–EX-200CLA145
In Commercial Distribution

  • 10852528005916 ()

  • Intro Sheath: 6 Fr
  • Max OD: 0.079 inches
  • Crown Type: Classic
  • High Speed: 140 krpm
  • Medium Speed: 90 krpm
  • Low Speed: 60 krpm
  • Guidewire: 0.014 inches
  • Shaft Length: 145 cm
  • Nose Length: 20 mm
  • Crown Diameter: 2.00 mm
7-10030-11

  • Mechanical atherectomy system catheter, peripheral
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