FDA 510(k) Applications for Medical Device Product Code "MGZ"
(Valvulotome)
FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K965137 |
BAXTER EDWARDS |
FOGARTY VALVULOTOME MODEL 700091 |
06/04/1997 |
K001734 |
EDWARDS LIFESCIENCES, LLC. |
FOGARTY VALVULOTOME, MODEL 700091 |
03/26/2001 |
K022823 |
GEISTER MEDIZINTECHNIK GMBH |
VALVULOTOME, RETROGRADE : 03-7500- 03-7510, ANTEGRADE 03-7520 |
07/01/2004 |
K080178 |
KOVEN TECHNOLOGY, INC. |
VALVULOTOME BY KOVEN |
07/28/2008 |
K190267 |
LeMaitre Vascular |
EZE SIT Valvulotome |
10/30/2019 |
K140042 |
LEMAITRE VASCULAR, INC. |
1.5MM HYDRO EXPANDABLE LEMAITRE VALVULOTOME |
04/10/2014 |
K142660 |
LeMaitre Vascular, Inc. |
Antegrade LeMills Valvulotome |
10/17/2014 |
K132190 |
LEMAITRE VASCULAR, INC. |
EXPANDABLE LEMAITRE VALVULOTOME, OVER-THE-WIRE LEMAITRE VALVULOTOME |
08/05/2013 |
K132047 |
LEMAITRE VASCULAR, INC. |
LEMILLS VALVULOTOME |
11/05/2013 |
K111884 |
LEMAITRE VASCULAR, INC. |
OVER-THE-WIRE EXPANDABLE LEMAITRE VALVULOTOME |
07/29/2011 |
K221902 |
LimFlow, Inc. |
LimFlow Vector |
12/21/2022 |
K980723 |
VASCUTECH, INC. |
2.0MM EXPANDABLE LEMAITRE VALVULOTOME (ELV 2.0- GNT) |
02/12/1999 |
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