Devices

Device Recall HydroFinity Guidewire

  • Model / Serial
    Model HPSS35150- all lots.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Internationally to Italy, France, Norway, Sweden, Germany, Belgium, United Kingdom and Canada.
  • Product Description
    HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. || 0.035 OD, Stiff Shaft, Straight Tip, 150 CM Length; || Manufactured for Covidien, Plymouth, MN; || Manufactured by: NDC Inc., Fremont, CA. || Manufactured in Costa Rica || The HydroFinity Hydrophilic guidewire facilitates the introduction and placement of catheters and interventional devices to the desired anatomical location during diagnostic or interventional procedures.
  • Manufacturer
    Nitinol Devices and Components, Inc.
  • 1 Event

Manufacturer

Nitinol Devices and Components, Inc.
  • Manufacturer Address
    Nitinol Devices and Components, Inc., 47533 Westinghouse Dr, Fremont CA 94539-7463
  • Manufacturer Parent Company (2017)
    Nitinol Devices and Components, Inc.
  • Source
    USFDA

11 devices with a similar name

Learn more about the data here

Device Recall HydroFinity Guidewire
  • Model / Serial
    Model HPRA35150 - all lots.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Internationally to Italy, France, Norway, Sweden, Germany, Belgium, United Kingdom and Canada.
  • Product Description
    HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. || 0.035 OD, Standard Shaft, Angled Tip, 150 CM Length || Manufactured for Covidien, Plymouth, MN; || Manufactured by: NDC Inc., Fremont, CA. || Manufactured in Costa Rica || The HydroFinity Hydrophilic guidewire facilitates the introduction and placement of catheters and interventional devices to the desired anatomical location during diagnostic or interventional procedures.
  • Manufacturer
    Nitinol Devices and Components, Inc.
Device Recall HydroFinity Guidewire
  • Model / Serial
    Model HPRA35180 - all lots.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Internationally to Italy, France, Norway, Sweden, Germany, Belgium, United Kingdom and Canada.
  • Product Description
    HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. || 0.035 OD, Standard Shaft, Angled Tip, 180 CM Length; || Manufactured for Covidien, Plymouth, MN; || Manufactured by: NDC Inc., Fremont, CA. || Manufactured in Costa Rica || The HydroFinity Hydrophilic guidewire facilitates the introduction and placement of catheters and interventional devices to the desired anatomical location during diagnostic or interventional procedures.
  • Manufacturer
    Nitinol Devices and Components, Inc.
Device Recall HydroFinity Guidewire
  • Model / Serial
    Model HPRA35260- all lots.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Internationally to Italy, France, Norway, Sweden, Germany, Belgium, United Kingdom and Canada.
  • Product Description
    HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. || 0.035 OD, Standard Shaft, Angled Tip, 260 CM Length; || Manufactured for Covidien, Plymouth, MN; || Manufactured by: NDC Inc., Fremont, CA. || Manufactured in Costa Rica || The HydroFinity Hydrophilic guidewire facilitates the introduction and placement of catheters and interventional devices to the desired anatomical location during diagnostic or interventional procedures.
  • Manufacturer
    Nitinol Devices and Components, Inc.
Device Recall HydroFinity Guidewire
  • Model / Serial
    Model HPRS35150- all lots.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Internationally to Italy, France, Norway, Sweden, Germany, Belgium, United Kingdom and Canada.
  • Product Description
    HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. || 0.035 OD, Standard Shaft, Straight Tip, 150 CM Length || Manufactured for Covidien, Plymouth, MN; || Manufactured by: NDC Inc., Fremont, CA. || Manufactured in Costa Rica || The HydroFinity Hydrophilic guidewire facilitates the introduction and placement of catheters and interventional devices to the desired anatomical location during diagnostic or interventional procedures.
  • Manufacturer
    Nitinol Devices and Components, Inc.
Device Recall HydroFinity Guidewire
  • Model / Serial
    Model HPRS35180- all lots.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Internationally to Italy, France, Norway, Sweden, Germany, Belgium, United Kingdom and Canada.
  • Product Description
    HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile.Nitinol Guidewire with Hydrophilic Coating, Sterile. || 0.035 OD, Standard Shaft, Straight Tip, 180 CM Length; || Manufactured for Covidien, Plymouth, MN; || Manufactured by: NDC Inc., Fremont, CA. || Manufactured in Costa Rica || The HydroFinity Hydrophilic guidewire facilitates the introduction and placement of catheters and interventional devices to the desired anatomical location during diagnostic or interventional procedures.
  • Manufacturer
    Nitinol Devices and Components, Inc.
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