Product code MGZ— Cardiovascular

FDA has cleared 27 devices under product code MGZ between 1991 and 2026, filed by 17 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 20261 clearance
• 20251 clearance
• 20221 clearance
• 20191 clearance
• 20142 clearances
• 20132 clearances
• 20111 clearance
• 20081 clearance
• 20041 clearance
• 20011 clearance
• 19991 clearance
• 19971 clearance
• 19951 clearance
• 19941 clearance
• 19934 clearances

• LeMaitre Vascular, Inc.5 clearances
• Vascutech, Inc.4 clearances
• LimFlow, Inc.2 clearances
• Intramed Laboratories, Inc.2 clearances
• Cardio Source2 clearances
• Uresil Corp.1 clearance
• Scanlan Intl., Inc.1 clearance
• Pilling Co.1 clearance
• Olympus Corp.1 clearance
• Nobles-Lai Engineering, Inc.1 clearance

• K260188 — LimFlow VectorLimFlow, Inc.·2026-03-18
• K250105 — Boomerang Valvulotome (BMGVT080); Boomerang Push Valvulotome (BMGPVT125)Aveera Medical, Inc.·2025-07-03
• K221902 — LimFlow VectorLimFlow, Inc.·2022-12-21
• K190267 — EZE SIT ValvulotomeLemaitre Vascular·2019-10-30
• K142660 — Antegrade LeMills ValvulotomeLeMaitre Vascular, Inc.·2014-10-17
• K140042 — 1.5MM HYDRO EXPANDABLE LEMAITRE VALVULOTOMELeMaitre Vascular, Inc.·2014-04-10
• K132047 — LEMILLS VALVULOTOMELeMaitre Vascular, Inc.·2013-11-05
• K132190 — EXPANDABLE LEMAITRE VALVULOTOME, OVER-THE-WIRE LEMAITRE VALVULOTOMELeMaitre Vascular, Inc.·2013-08-05
• K111884 — OVER-THE-WIRE EXPANDABLE LEMAITRE VALVULOTOMELeMaitre Vascular, Inc.·2011-07-29
• K080178 — VALVULOTOME BY KOVENKoven Technology, Inc.·2008-07-28
• K022823 — VALVULOTOME, RETROGRADE : 03-7500- 03-7510, ANTEGRADE 03-7520Geister Medizin Technik GmbH·2004-07-01
• K001734 — FOGARTY VALVULOTOME, MODEL 700091Edwards Lifesciences, LLC·2001-03-26
• K980723 — 2.0MM EXPANDABLE LEMAITRE VALVULOTOME (ELV 2.0- GNT)Vascutech, Inc.·1999-02-12
• K965137 — FOGARTY VALVULOTOME MODEL 700091Baxter Edwards·1997-06-04
• K946352 — LEMAITRE VALVULOTOME IIVascutech, Inc.·1995-06-21
• K925283 — VALVULOTOMEIntramed Laboratories, Inc.·1994-02-10
• K932009 — THE SAMUELS RETROGRAD VALVULOTOMEVascutech, Inc.·1993-09-21
• K930011 — URESIL VALVE CUTTER WITH INTERCHANGEABLE HEADSUresil Corp.·1993-05-26
• K924171 — LEMAITRE RETROGRADE VALVULOTOMEVascutech, Inc.·1993-02-16
• K924075 — DISPOSABLE OPTICAL VALVULOTOMEEndovascular, Inc.·1993-02-08
• K914385 — OPTICAL VALVULOTOMEIntramed Laboratories, Inc.·1992-03-02
• K911184 — SCANLAN/TAHERI VALVULOTOMEScanlan Intl., Inc.·1992-02-18
• K914457 — DISPOSABLE OPTICAL VALVULOTOMENobles-Lai Engineering, Inc.·1992-02-05
• K911702 — OLYMPUS RETRACTABLE VALVULOTOMEOlympus Corp.·1991-12-27
• K912635 — ANNULUS DISPOSABLE VALVULOTOMECardio Source·1991-10-18
• K912636 — ANNULUS VALVULOTOMECardio Source·1991-10-18
• K911100 — MEHIGAN-PILLING PHLEBETOME TMPilling Co.·1991-06-21