FDA-Device2014-07-02Class I
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.
Nitinol Devices and Components, Inc.
Hazard
Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire.
Sold states
Worldwide Distribution - USA (nationwide) and Internationally to Italy, France, Norway, Sweden, Germany, Belgium, United Kingdom and Canada.
Affected count
8485 in US, 9595 - ROW - total, all models
Manufactured in
47533 Westinghouse Dr, N/A, Fremont, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1812-2014Don't want to check this manually?
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