Atlas FDA

MGZ

27 FDA 510(k) clearances · Product code

163 daysmedian time to decision
353 days90th percentile
27clearances measured

FDA profile

Official device name
Valvulotome
Device class
Class II (moderate risk)
Regulation
21 CFR 870.4885
Medical specialty
Cardiovascular
Flags
Third-party review eligible
Adverse events (MAUDE)
2006: 2 · 2009: 3 · 2017: 21 · 2019: 19 · 2022: 13 · 2023: 23
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
LimFlow Vector (K260188)LimFlow, Inc.2026-03-18
Boomerang Valvulotome (BMGVT080); Boomerang Push Valvulotome (BMGPVT125) (K250105)Aveera Medical, Inc.2025-07-03
LimFlow Vector (K221902)LimFlow, Inc.2022-12-21
EZE SIT Valvulotome (K190267)Lemaitre Vascular2019-10-30
Antegrade LeMills Valvulotome (K142660)LeMaitre Vascular, Inc.2014-10-17
1.5MM HYDRO EXPANDABLE LEMAITRE VALVULOTOME (K140042)LeMaitre Vascular, Inc.2014-04-10
LEMILLS VALVULOTOME (K132047)LeMaitre Vascular, Inc.2013-11-05
EXPANDABLE LEMAITRE VALVULOTOME, OVER-THE-WIRE LEMAITRE VALVULOTOME (K132190)LeMaitre Vascular, Inc.2013-08-05
OVER-THE-WIRE EXPANDABLE LEMAITRE VALVULOTOME (K111884)LeMaitre Vascular, Inc.2011-07-29
VALVULOTOME BY KOVEN (K080178)Koven Technology, Inc.2008-07-28
VALVULOTOME, RETROGRADE : 03-7500- 03-7510, ANTEGRADE 03-7520 (K022823)Geister Medizin Technik GmbH2004-07-01
FOGARTY VALVULOTOME, MODEL 700091 (K001734)Edwards Lifesciences, LLC2001-03-26
2.0MM EXPANDABLE LEMAITRE VALVULOTOME (ELV 2.0- GNT) (K980723)Vascutech, Inc.1999-02-12
FOGARTY VALVULOTOME MODEL 700091 (K965137)Baxter Edwards1997-06-04
LEMAITRE VALVULOTOME II (K946352)Vascutech, Inc.1995-06-21
VALVULOTOME (K925283)Intramed Laboratories, Inc.1994-02-10
THE SAMUELS RETROGRAD VALVULOTOME (K932009)Vascutech, Inc.1993-09-21
URESIL VALVE CUTTER WITH INTERCHANGEABLE HEADS (K930011)Uresil Corp.1993-05-26
LEMAITRE RETROGRADE VALVULOTOME (K924171)Vascutech, Inc.1993-02-16
DISPOSABLE OPTICAL VALVULOTOME (K924075)Endovascular, Inc.1993-02-08
OPTICAL VALVULOTOME (K914385)Intramed Laboratories, Inc.1992-03-02
SCANLAN/TAHERI VALVULOTOME (K911184)Scanlan Intl., Inc.1992-02-18
DISPOSABLE OPTICAL VALVULOTOME (K914457)Nobles-Lai Engineering, Inc.1992-02-05
OLYMPUS RETRACTABLE VALVULOTOME (K911702)Olympus Corp.1991-12-27
ANNULUS VALVULOTOME (K912636)Cardio Source1991-10-18
ANNULUS DISPOSABLE VALVULOTOME (K912635)Cardio Source1991-10-18
MEHIGAN-PILLING PHLEBETOME TM (K911100)Pilling Co.1991-06-21

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Every clearance here is in the API, with alerts when new ones post.