Product code MGZ
- Device name
- Valvulotome
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation number
- 870.4885
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260188 | LimFlow Vector | LimFlow, Inc. | 2026-03-18 |
| K250105 | Boomerang Valvulotome (BMGVT080); Boomerang Push Valvulotome (BMGPVT125) | Aveera Medical, Inc. | 2025-07-03 |
| K221902 | LimFlow Vector | LimFlow, Inc. | 2022-12-21 |
| K190267 | EZE SIT Valvulotome | Lemaitre Vascular | 2019-10-30 |
| K142660 | Antegrade LeMills Valvulotome | LeMaitre Vascular, Inc. | 2014-10-17 |
| K140042 | 1.5MM HYDRO EXPANDABLE LEMAITRE VALVULOTOME | LeMaitre Vascular, Inc. | 2014-04-10 |
| K132047 | LEMILLS VALVULOTOME | LeMaitre Vascular, Inc. | 2013-11-05 |
| K132190 | EXPANDABLE LEMAITRE VALVULOTOME, OVER-THE-WIRE LEMAITRE VALVULOTOME | LeMaitre Vascular, Inc. | 2013-08-05 |
| K111884 | OVER-THE-WIRE EXPANDABLE LEMAITRE VALVULOTOME | LeMaitre Vascular, Inc. | 2011-07-29 |
| K080178 | VALVULOTOME BY KOVEN | Koven Technology, Inc. | 2008-07-28 |
| K022823 | VALVULOTOME, RETROGRADE : 03-7500- 03-7510, ANTEGRADE 03-7520 | Geister Medizin Technik GmbH | 2004-07-01 |
| K001734 | FOGARTY VALVULOTOME, MODEL 700091 | Edwards Lifesciences, LLC | 2001-03-26 |
| K980723 | 2.0MM EXPANDABLE LEMAITRE VALVULOTOME (ELV 2.0- GNT) | Vascutech, Inc. | 1999-02-12 |
| K965137 | FOGARTY VALVULOTOME MODEL 700091 | Baxter Edwards | 1997-06-04 |
| K946352 | LEMAITRE VALVULOTOME II | Vascutech, Inc. | 1995-06-21 |
| K925283 | VALVULOTOME | Intramed Laboratories, Inc. | 1994-02-10 |
| K932009 | THE SAMUELS RETROGRAD VALVULOTOME | Vascutech, Inc. | 1993-09-21 |
| K930011 | URESIL VALVE CUTTER WITH INTERCHANGEABLE HEADS | Uresil Corp. | 1993-05-26 |
| K924171 | LEMAITRE RETROGRADE VALVULOTOME | Vascutech, Inc. | 1993-02-16 |
| K924075 | DISPOSABLE OPTICAL VALVULOTOME | Endovascular, Inc. | 1993-02-08 |
| K914385 | OPTICAL VALVULOTOME | Intramed Laboratories, Inc. | 1992-03-02 |
| K911184 | SCANLAN/TAHERI VALVULOTOME | Scanlan Intl., Inc. | 1992-02-18 |
| K914457 | DISPOSABLE OPTICAL VALVULOTOME | Nobles-Lai Engineering, Inc. | 1992-02-05 |
| K911702 | OLYMPUS RETRACTABLE VALVULOTOME | Olympus Corp. | 1991-12-27 |
| K912635 | ANNULUS DISPOSABLE VALVULOTOME | Cardio Source | 1991-10-18 |
| K912636 | ANNULUS VALVULOTOME | Cardio Source | 1991-10-18 |
| K911100 | MEHIGAN-PILLING PHLEBETOME TM | Pilling Co. | 1991-06-21 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00860013182304 | Boomerang | Aveera Medical Inc. | 2025-07-14 |
| 00860013182311 | Boomerang | Aveera Medical Inc. | 2025-07-14 |
| 00850041730134 | LimFlow Vector | Inari Medical, Inc. | 2024-04-12 |
| 00850041730028 | LimFlow Vector | Inari Medical, Inc. | 2023-06-26 |
| 00840663102297 | Eze-Sit Valvulotome | Lemaitre Vascular, Inc. | 2022-06-30 |
| H862TIVCNC0 | Tru-Incise Valvulotome with Interchangeable Heads | URESIL, LLC | 2019-09-17 |
| H862TIVH20NC0 | Tru-Incise Valvulotome with Interchangeable Heads | URESIL, LLC | 2019-09-17 |
| H862TIVH30NC0 | Tru-Incise Valvulotome with Interchangeable Heads | URESIL, LLC | 2019-09-17 |
| H862TIVK2030NC2 | Tru-Incise Valvulotome with Interchangeable Heads | URESIL, LLC | 2019-09-11 |
| H862TIVH40NC0 | Tru-Incise Valvulotome with Interchangeable Heads | URESIL, LLC | 2019-09-11 |
| H862TIVK2030NC0 | Tru-Incise Valvulotome with Interchangeable Heads | URESIL, LLC | 2019-09-11 |
| M944AL103110 | Wexler Surgical, Inc. | WEXLER SURGICAL, INC. | 2016-12-20 |
| M944AL103010 | Wexler Surgical, Inc. | WEXLER SURGICAL, INC. | 2016-12-19 |
| H862TIVH400 | Tru-Incise Valvulotome with Interchangeable Heads | URESIL, LLC | 2016-08-31 |
| H862TIVC0 | Tru-Incise Valvulotome with Interchangeable Heads | URESIL, LLC | 2016-08-31 |
| H862TIVH300 | Tru-Incise Valvulotome with Interchangeable Heads | URESIL, LLC | 2016-08-31 |
| H862TIVH402 | Tru-Incise Valvulotome with Interchangeable Heads | URESIL, LLC | 2016-08-31 |
| H862TIVK20302 | Tru-Incise Valvulotome with Interchangeable Heads | URESIL, LLC | 2016-08-31 |
| H862TIVH200 | Tru-Incise Valvulotome with Interchangeable Heads | URESIL, LLC | 2016-08-31 |
| H862TIVK20300 | Tru-Incise Valvulotome with Interchangeable Heads | URESIL, LLC | 2016-08-31 |
| 00840663106721 | Expandable LeMaitre Valvulotome | Lemaitre Vascular, Inc. | 2015-07-15 |
| 00840663100101 | Expandable LeMaitre Valvulotome | Lemaitre Vascular, Inc. | 2015-06-30 |
| 00840663100118 | Expandable LeMaitre Valvulotome | Lemaitre Vascular, Inc. | 2015-06-30 |
| 00840663100132 | Over-the-Wire LeMaitre Valvulotome | Lemaitre Vascular, Inc. | 2015-06-30 |
| 00840663100149 | Over-the-Wire LeMaitre Valvulotome | Lemaitre Vascular, Inc. | 2015-06-30 |
| 00840663100163 | Over-the-Wire LeMaitre Valvulotome | Lemaitre Vascular, Inc. | 2015-06-30 |
| 00840663100309 | Expandable LeMaitre Valvulotome | Lemaitre Vascular, Inc. | 2015-06-30 |
| 00840663106653 | HYDRO LeMaitre Valvulotome | Lemaitre Vascular, Inc. | 2015-06-30 |
| 00840663106660 | HYDRO LeMaitre Valvulotome | Lemaitre Vascular, Inc. | 2015-06-30 |
| 00840663100095 | Expandable LeMaitre Valvulotome | Lemaitre Vascular, Inc. | 2015-06-30 |