FDA Product Code
FDA Product Code MGZ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.4885
510(k) Clearances — 27 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K260188 | LimFlow Vector | LimFlow, Inc. | 2026-03-18 | Special | PDF ↗ |
| K250105 | Boomerang Valvulotome (BMGVT080); Boomerang Push Valvulotome (BMGPVT125) | Aveera Medical, Inc. | 2025-07-03 | Traditional | PDF ↗ |
| K221902 | LimFlow Vector | LimFlow, Inc. | 2022-12-21 | Traditional | PDF ↗ |
| K190267 | EZE SIT Valvulotome | Lemaitre Vascular | 2019-10-30 | Traditional | PDF ↗ |
| K142660 | Antegrade LeMills Valvulotome | LeMaitre Vascular, Inc. | 2014-10-17 | Special | PDF ↗ |
| K140042 | 1.5MM HYDRO EXPANDABLE LEMAITRE VALVULOTOME | LeMaitre Vascular, Inc. | 2014-04-10 | Traditional | PDF ↗ |
| K132047 | LEMILLS VALVULOTOME | LeMaitre Vascular, Inc. | 2013-11-05 | Traditional | PDF ↗ |
| K132190 | EXPANDABLE LEMAITRE VALVULOTOME, OVER-THE-WIRE LEMAITRE VALVULOTOME | LeMaitre Vascular, Inc. | 2013-08-05 | Traditional | PDF ↗ |
| K111884 | OVER-THE-WIRE EXPANDABLE LEMAITRE VALVULOTOME | LeMaitre Vascular, Inc. | 2011-07-29 | Special | PDF ↗ |
| K080178 | VALVULOTOME BY KOVEN | Koven Technology, Inc. | 2008-07-28 | Traditional | PDF ↗ |
| K022823 | VALVULOTOME, RETROGRADE : 03-7500- 03-7510, ANTEGRADE 03-7520 | Geister Medizin Technik GmbH | 2004-07-01 | Traditional | PDF ↗ |
| K001734 | FOGARTY VALVULOTOME, MODEL 700091 | Edwards Lifesciences, LLC | 2001-03-26 | Traditional | PDF ↗ |
| K980723 | 2.0MM EXPANDABLE LEMAITRE VALVULOTOME (ELV 2.0- GNT) | Vascutech, Inc. | 1999-02-12 | Traditional | PDF ↗ |
| K965137 | FOGARTY VALVULOTOME MODEL 700091 | Baxter Edwards | 1997-06-04 | Traditional | PDF ↗ |
| K946352 | LEMAITRE VALVULOTOME II | Vascutech, Inc. | 1995-06-21 | Traditional | PDF ↗ |
| K925283 | VALVULOTOME | Intramed Laboratories, Inc. | 1994-02-10 | Traditional | PDF ↗ |
| K932009 | THE SAMUELS RETROGRAD VALVULOTOME | Vascutech, Inc. | 1993-09-21 | Traditional | PDF ↗ |
| K930011 | URESIL VALVE CUTTER WITH INTERCHANGEABLE HEADS | Uresil Corp. | 1993-05-26 | Traditional | PDF ↗ |
| K924171 | LEMAITRE RETROGRADE VALVULOTOME | Vascutech, Inc. | 1993-02-16 | Traditional | PDF ↗ |
| K924075 | DISPOSABLE OPTICAL VALVULOTOME | Endovascular, Inc. | 1993-02-08 | Traditional | PDF ↗ |
| K914385 | OPTICAL VALVULOTOME | Intramed Laboratories, Inc. | 1992-03-02 | Traditional | PDF ↗ |
| K911184 | SCANLAN/TAHERI VALVULOTOME | Scanlan Intl., Inc. | 1992-02-18 | Traditional | PDF ↗ |
| K914457 | DISPOSABLE OPTICAL VALVULOTOME | Nobles-Lai Engineering, Inc. | 1992-02-05 | Traditional | PDF ↗ |
| K911702 | OLYMPUS RETRACTABLE VALVULOTOME | Olympus Corp. | 1991-12-27 | Traditional | PDF ↗ |
| K912636 | ANNULUS VALVULOTOME | Cardio Source | 1991-10-18 | Traditional | PDF ↗ |
| K912635 | ANNULUS DISPOSABLE VALVULOTOME | Cardio Source | 1991-10-18 | Traditional | PDF ↗ |
| K911100 | MEHIGAN-PILLING PHLEBETOME TM | Pilling Co. | 1991-06-21 | Traditional | PDF ↗ |
Product code MGZ · Class II · Cardiovascular. Data: openFDA.