MGZ · Class II · 21 CFR 870.4885

FDA Product Code MGZ: Valvulotome

Leading manufacturers include LeMaitre Vascular, Inc., LimFlow, Inc. and Olympus Corp..

27
Total
27
Cleared
191d
Avg days
1991
Since
Growing category - 2 submissions in the last 2 years vs 1 in the prior period
Review times improving: avg 112d recently vs 197d historically

FDA 510(k) Cleared Valvulotome Devices (Product Code MGZ)

27 devices
1–24 of 27
Cleared Mar 18, 2026
LimFlow Vector
K260188
LimFlow, Inc.
Cardiovascular · 55d
Cleared Jul 03, 2025
Boomerang Valvulotome (BMGVT080)
K250105
Aveera Medical, Inc.
Cardiovascular · 169d
Cleared Dec 21, 2022
LimFlow Vector
K221902
LimFlow, Inc.
Cardiovascular · 174d
Cleared Oct 30, 2019
EZE SIT Valvulotome
K190267
Lemaitre Vascular
Cardiovascular · 264d
Cleared Oct 17, 2014
Antegrade LeMills Valvulotome
K142660
LeMaitre Vascular, Inc.
Cardiovascular · 29d
Cleared Apr 10, 2014
1.5MM HYDRO EXPANDABLE LEMAITRE VALVULOTOME
K140042
LeMaitre Vascular, Inc.
Cardiovascular · 92d
Cleared Nov 05, 2013
LEMILLS VALVULOTOME
K132047
LeMaitre Vascular, Inc.
Cardiovascular · 126d
Cleared Aug 05, 2013
EXPANDABLE LEMAITRE VALVULOTOME, OVER-THE-WIRE LEMAITRE VALVULOTOME
K132190
LeMaitre Vascular, Inc.
Cardiovascular · 21d
Cleared Jul 29, 2011
OVER-THE-WIRE EXPANDABLE LEMAITRE VALVULOTOME
K111884
LeMaitre Vascular, Inc.
Cardiovascular · 28d
Cleared Jul 28, 2008
VALVULOTOME BY KOVEN
K080178
Koven Technology, Inc.
Cardiovascular · 186d
Cleared Mar 26, 2001
FOGARTY VALVULOTOME, MODEL 700091
K001734
Edwards Lifesciences, LLC
Cardiovascular · 292d
Cleared Feb 12, 1999
2.0MM EXPANDABLE LEMAITRE VALVULOTOME (ELV 2.0- GNT)
K980723
Vascutech, Inc.
Cardiovascular · 353d
Cleared Jun 04, 1997
FOGARTY VALVULOTOME MODEL 700091
K965137
Baxter Edwards
Cardiovascular · 163d
Cleared May 26, 1993
URESIL VALVE CUTTER WITH INTERCHANGEABLE HEADS
K930011
Uresil Corp.
Cardiovascular · 142d
Cleared Feb 18, 1992
SCANLAN/TAHERI VALVULOTOME
K911184
Scanlan Intl., Inc.
Cardiovascular · 337d
Cleared Dec 27, 1991
OLYMPUS RETRACTABLE VALVULOTOME
K911702
Olympus Corp.
Cardiovascular · 255d
Cleared Jun 21, 1991
MEHIGAN-PILLING PHLEBETOME TM
K911100
Pilling Co.
Cardiovascular · 101d

About Product Code MGZ - Regulatory Context

510(k) Submission Activity

27 total 510(k) submissions under product code MGZ since 1991, with 27 receiving FDA clearance (average review time: 191 days).

Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - MGZ Product Code

Recent submissions under MGZ have taken an average of 112 days to reach a decision - down from 197 days historically, suggesting improved FDA processing for this classification.

MGZ devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →