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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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Control 9F Mechanical Thrombectomy System, 90cm - B090A90900

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.
A9-090
In Commercial Distribution

  • B090A90901 ()
  • B090A90900 ()
  • B090A90902 ()

  • Catheter Working Length: 90 Centimeter
  • Catheter Gauge: 9 French
A9-090

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

Control 9F Mechanical Thrombectomy System, 60cm - B090A90600

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

Control 7F Mechanical Thrombectomy System - B090A70900

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

Control 7F Mechanical Thrombectomy System - B090A70600

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 Aspiration Catheter 135cm - B090A61350

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 Aspiration Catheter 55cm - B090A60550

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 Aspiration Catheter 135cm - B090A51350

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

Aspire Max 5 Aspiration Catheter 55cm - B090A50550

ASPIRE MAX 5 Mechanical Thrombectomy Systems™ for removal of fresh, soft emboli and thrombi from vessels in the peripheral vasculature.
ZIEN MEDICAL TECHNOLOGIES, INC.
A5-055
In Commercial Distribution

  • B090A50552 ()
  • B090A50551 ()
  • B090A50550 ()
A5-055

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

Control 11F Mechanical Thrombectomy System - B090A110900

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.
A11-090
In Commercial Distribution

  • B090A110901 ()
  • B090A110900 ()
  • B090A110902 ()

  • Catheter Working Length: 90 Centimeter
  • Catheter Gauge: 11 French
A11-090

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

Control 11F Mechanical Thrombectomy System, 60cm - B090A110600

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.
A11-060
In Commercial Distribution

  • B090A110601 ()
  • B090A110600 ()
  • B090A110602 ()

  • Catheter Working Length: 60 Centimeter
  • Catheter Gauge: 11 French
A11-060

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