510(k) K140042 ยท MGZ Valvulotome
1.5MM HYDRO EXPANDABLE LEMAITRE VALVULOTOME
| Applicant | LeMaitre Vascular, Inc., Burlington MA, US |
| Decision | Substantially Equivalent, Apr 10, 2014 |
| Received | Jan 8, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K140042
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 3, 2016 | LeMaitre Vascular, Inc. 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 o Terminated |
MGZ | None listed |
| Aug 3, 2016 | LeMaitre Vascular, Inc. 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 Terminated |
MGZ | None listed |
| Aug 3, 2016 | LeMaitre Vascular, Inc. 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 Terminated |
MGZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.