FDA-Device2016-08-24Class II
1.5 mm HYDRO LeMaitre Valvulotome without LeMills, 98 cm. Sterile REF# 1009-00J Product Usage: The HYDRO LeMaitre Valvulotome is intended for the treatment of vascular disorders and more particularly for excising or disrupting venous valves
LeMaitre Vascular, Inc.
Hazard
Wire which deploys the loop may be come detached at the handle causing the device to be inoperable
Sold states
Worldwide Distribution - US Nationwide and in the countries of Australia, BELGIUM, BRAZIL, CANADA, Czech Republic, DENMARK, FINLAND, FRANCE, GERMANY, Italy, Japan, NETHERLANDS, Russia, Spain, SWEDEN, Switzerland, and UK.
Affected count
380 units
Manufactured in
63 2nd Ave, N/A, Burlington, MA, United States
Products
1.5 mm HYDRO LeMaitre Valvulotome without LeMills, 98 cm. Sterile REF# 1009-00J Product Usage: The HYDRO LeMaitre Valvulotome is intended for the treatment of vascular disorders and more particularly for excising or disrupting venous valves
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2544-2016Don't want to check this manually?
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