Panels › Cardiovascular › Product code MGZ · Class 2
Valvulotome
Regulation 870.4885
1510(k)s in 12 months (27 all time)
1recalls in 12 months (6 all time)
4recalls that name a 510(k)
Top companies in MGZ
| Company | 510(k)s | Recalls |
|---|---|---|
| LeMaitre Vascular, Inc. | 6 | 4 |
| Vascutech, Inc. | 4 | 0 |
| LimFlow, Inc. | 2 | 1 |
| Cardio Source | 2 | 0 |
| Intramed Laboratories, Inc. | 2 | 0 |
| Aveera Medical, Inc. | 1 | 0 |
| Baxter Edwards | 1 | 0 |
| Edwards Lifesciences, LLC | 1 | 0 |
| Endovascular, Inc. | 1 | 0 |
| Geister Medizin Technik GmbH | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 18, 2026 | K260188 | LimFlow Vector LimFlow, Inc. | MGZ |
| Jul 3, 2025 | K250105 | Boomerang Valvulotome (BMGVT080); Boomerang Push Valvulotome (BMGPVT125) Aveera Medical, Inc. | MGZ |
| Dec 21, 2022 | K221902 | LimFlow Vector LimFlow, Inc. | MGZ |
| Oct 30, 2019 | K190267 | EZE SIT Valvulotome Lemaitre Vascular | MGZ |
| Oct 17, 2014 | K142660 | Antegrade LeMills Valvulotome LeMaitre Vascular, Inc. | MGZ |
| Apr 10, 2014 | K140042 | 1.5MM HYDRO EXPANDABLE LEMAITRE VALVULOTOME LeMaitre Vascular, Inc. | MGZ |
| Nov 5, 2013 | K132047 | LEMILLS VALVULOTOME LeMaitre Vascular, Inc. | MGZ |
| Aug 5, 2013 | K132190 | EXPANDABLE LEMAITRE VALVULOTOME, OVER-THE-WIRE LEMAITRE VALVULOTOME LeMaitre Vascular, Inc. | MGZ |
| Jul 29, 2011 | K111884 | OVER-THE-WIRE EXPANDABLE LEMAITRE VALVULOTOME LeMaitre Vascular, Inc. | MGZ |
| Jul 28, 2008 | K080178 | VALVULOTOME BY KOVEN Koven Technology, Inc. | MGZ |
| Jul 1, 2004 | K022823 | VALVULOTOME, RETROGRADE : 03-7500- 03-7510, ANTEGRADE 03-7520 Geister Medizin Technik GmbH | MGZ |
| Mar 26, 2001 | K001734 | FOGARTY VALVULOTOME, MODEL 700091 Edwards Lifesciences, LLC | MGZ |
| Feb 12, 1999 | K980723 | 2.0MM EXPANDABLE LEMAITRE VALVULOTOME (ELV 2.0- GNT) Vascutech, Inc. | MGZ |
| Jun 4, 1997 | K965137 | FOGARTY VALVULOTOME MODEL 700091 Baxter Edwards | MGZ |
| Jun 21, 1995 | K946352 | LEMAITRE VALVULOTOME II Vascutech, Inc. | MGZ |
| Feb 10, 1994 | K925283 | VALVULOTOME Intramed Laboratories, Inc. | MGZ |
| Sep 21, 1993 | K932009 | THE SAMUELS RETROGRAD VALVULOTOME Vascutech, Inc. | MGZ |
| May 26, 1993 | K930011 | URESIL VALVE CUTTER WITH INTERCHANGEABLE HEADS Uresil Corp. | MGZ |
| Feb 16, 1993 | K924171 | LEMAITRE RETROGRADE VALVULOTOME Vascutech, Inc. | MGZ |
| Feb 8, 1993 | K924075 | DISPOSABLE OPTICAL VALVULOTOME Endovascular, Inc. | MGZ |
| Mar 2, 1992 | K914385 | OPTICAL VALVULOTOME Intramed Laboratories, Inc. | MGZ |
| Feb 18, 1992 | K911184 | SCANLAN/TAHERI VALVULOTOME Scanlan Intl., Inc. | MGZ |
| Feb 5, 1992 | K914457 | DISPOSABLE OPTICAL VALVULOTOME Nobles-Lai Engineering, Inc. | MGZ |
| Dec 27, 1991 | K911702 | OLYMPUS RETRACTABLE VALVULOTOME Olympus Corp. | MGZ |
| Oct 18, 1991 | K912636 | ANNULUS VALVULOTOME Cardio Source | MGZ |
| Oct 18, 1991 | K912635 | ANNULUS DISPOSABLE VALVULOTOME Cardio Source | MGZ |
| Jun 21, 1991 | K911100 | MEHIGAN-PILLING PHLEBETOME TM Pilling Co. | MGZ |
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