1.5MM HYDRO EXPANDABLE LEMAITRE VALVULOTOME— 510(k) K140042
Substantially EquivalentLeMaitre Vascular, Inc.
FDA 510(k) clearance K140042 for 1.5MM HYDRO EXPANDABLE LEMAITRE VALVULOTOME, Substantially Equivalent on 2014-04-10. Applicant: LeMaitre Vascular, Inc.. Device class: 2.
Clearance details
- Applicant
- LeMaitre Vascular, Inc.
- Product code
- Code MGZ
- Device class
- Class 2
- Regulation
- 21 CFR 870.4885
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Burlington, MA, US
Recent devices under product code MGZ
view allMore clearances from LeMaitre Vascular, Inc.
view allRecalls naming K140042
K-number listed on FDA's recall record- Z-2543-2016 — 1.5 mm HYDRO LeMaitre Valvulotome, 98 cm, Sterile REF # 1009-00 Product Usage: The HYDRO LeMaitre Valvulotome is intended for the treatment of vascular disorders and more particularly for excising or disrupting venous valves
- Z-2544-2016 — 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
- Z-2545-2016 — 1.5 mm HYDRO LeMaitre Valvulotome, 40 cm. Sterile REF # 1010-00 Product Usage: The HYDRO LeMaitre Valvulotome is intended for the treatment of vascular disorders and more particularly for excising or disrupting venous valves
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K140042.
Data sourced from openFDA. This site is unofficial and independent of the FDA.