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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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The Control 7-11F Mechanical Thrombectomy System and Control Mechanical Aspirator are indicated for the removal of fresh soft emboli and thrombi from vessels in the peripheral vasculature.
ZIEN MEDICAL TECHNOLOGIES, INC.
ASP-1036
In Commercial Distribution

  • B090ASP10361 ()
  • B090ASP10360 ()
  • B090ASP10362 ()

  • Catheter Working Length: 60 Centimeter
  • Catheter Gauge: 11 French
ASP-1036

  • General-purpose syringe, single-use
  • Thrombectomy suction catheter
The CONTROL MECHANICAL ASPIRATOR is intended to aspirate fluids from the body
ZIEN MEDICAL TECHNOLOGIES, INC.
ASP-1029
In Commercial Distribution

  • B090ASP10291 ()
  • B090ASP10290 ()
  • B090ASP10292 ()
ASP-1029

  • General-purpose syringe, single-use
The Control 7-11F Mechanical Thrombectomy System and Control Mechanical Aspirator are indicated for the removal of fresh soft emboli and thrombi from vessels in the peripheral vasculature.
ZIEN MEDICAL TECHNOLOGIES, INC.
ASP-1013
In Commercial Distribution

  • B090ASP10131 ()
  • B090ASP10130 ()
  • B090ASP10132 ()

  • Catheter Working Length: 90 Centimeter
  • Catheter Gauge: 7 French
ASP-1013

  • General-purpose syringe, single-use
  • Thrombectomy suction catheter
ASPIRE RX-LP6 Mechanical Thrombectomy System™ and the ASPIRE Mechanical Aspirator™ Drive Unit / Pump for removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature.
ZIEN MEDICAL TECHNOLOGIES, INC.
ARX-LP6
In Commercial Distribution

  • B090ARXLP62 ()
  • B090ARXLP61 ()
  • B090ARXLP60 ()
ARX-LP6

  • General-purpose syringe, single-use
  • Thrombectomy suction catheter
The Control 7-11F Mechanical Thrombectomy System and Control Mechanical Aspirator are indicated for the removal of fresh soft emboli and thrombi from vessels in the peripheral vasculature.
ZIEN MEDICAL TECHNOLOGIES, INC.
A9-060
In Commercial Distribution

  • B090A90601 ()
  • B090A90600 ()
  • B090A90602 ()

  • Catheter Working Length: 60 Centimeter
  • Catheter Gauge: 9 French
A9-060

  • General-purpose syringe, single-use
  • Thrombectomy suction catheter
The Control 7-11F Mechanical Thrombectomy System and Control Mechanical Aspirator are indicated for the removal of fresh soft emboli and thrombi from vessels in the peripheral vasculature.
ZIEN MEDICAL TECHNOLOGIES, INC.
A7-090
In Commercial Distribution

  • B090A70901 ()
  • B090A70900 ()
  • B090A70902 ()

  • Catheter Working Length: 90 Centimeter
  • Catheter Gauge: 7 French
A7-090

  • General-purpose syringe, single-use
  • Thrombectomy suction catheter
The Control 7-11F Mechanical Thrombectomy System and Control Mechanical Aspirator are indicated for the removal of fresh soft emboli and thrombi from vessels in the peripheral vasculature.
ZIEN MEDICAL TECHNOLOGIES, INC.
A7-060
In Commercial Distribution

  • B090A70600 ()
  • B090A70601 ()
  • B090A70602 ()

  • Catheter Working Length: 60 Centimeter
  • Catheter Gauge: 7 French
A7-060

  • Thrombectomy suction catheter
  • General-purpose syringe, single-use
ASPIRE MAX 6 Mechanical Thrombectomy Systems™ for removal of fresh, soft emboli and thrombi from vessels in the peripheral vasculature.
ZIEN MEDICAL TECHNOLOGIES, INC.
A6-135
In Commercial Distribution

  • B090A61352 ()
  • B090A61351 ()
  • B090A61350 ()
A6-135

  • Thrombectomy suction catheter
  • General-purpose syringe, single-use
ASPIRE MAX 6 Mechanical Thrombectomy Systems™ for removal of fresh, soft emboli and thrombi from vessels in the peripheral vasculature.
ZIEN MEDICAL TECHNOLOGIES, INC.
A6-055
In Commercial Distribution

  • B090A60550 ()
  • B090A60551 ()
  • B090A60552 ()
A6-055

  • General-purpose syringe, single-use
  • Thrombectomy suction catheter
ASPIRE MAX 5 Mechanical Thrombectomy Systems™ for removal of fresh, soft emboli and thrombi from vessels in the peripheral vasculature.
ZIEN MEDICAL TECHNOLOGIES, INC.
A5-135
In Commercial Distribution

  • B090A51352 ()
  • B090A51351 ()
  • B090A51350 ()
A5-135

  • General-purpose syringe, single-use
  • Thrombectomy suction catheter
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