MGZ — Valvulotome Class II
FDA Device Classification
Classification Details
- Product Code
- MGZ
- Device Class
- Class II
- Regulation Number
- 870.4885
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K250105 | aveera medical | Boomerang Valvulotome (BMGVT080); Boomerang Push Valvulotome (BMGPVT125) | July 3, 2025 |
| K221902 | limflow | LimFlow Vector | December 21, 2022 |
| K190267 | lemaitre vascular | EZE SIT Valvulotome | October 30, 2019 |
| K142660 | lemaitre vascular | Antegrade LeMills Valvulotome | October 17, 2014 |
| K140042 | lemaitre vascular | 1.5MM HYDRO EXPANDABLE LEMAITRE VALVULOTOME | April 10, 2014 |
| K132047 | lemaitre vascular | LEMILLS VALVULOTOME | November 5, 2013 |
| K132190 | lemaitre vascular | EXPANDABLE LEMAITRE VALVULOTOME, OVER-THE-WIRE LEMAITRE VALVULOTOME | August 5, 2013 |
| K111884 | lemaitre vascular | OVER-THE-WIRE EXPANDABLE LEMAITRE VALVULOTOME | July 29, 2011 |
| K080178 | koven technology | VALVULOTOME BY KOVEN | July 28, 2008 |
| K022823 | geister medizin technik | VALVULOTOME, RETROGRADE : 03-7500- 03-7510, ANTEGRADE 03-7520 | July 1, 2004 |
| K001734 | edwards lifesciences | FOGARTY VALVULOTOME, MODEL 700091 | March 26, 2001 |
| K980723 | vascutech | 2.0MM EXPANDABLE LEMAITRE VALVULOTOME (ELV 2.0- GNT) | February 12, 1999 |
| K965137 | baxter edwards | FOGARTY VALVULOTOME MODEL 700091 | June 4, 1997 |
| K946352 | vascutech | LEMAITRE VALVULOTOME II | June 21, 1995 |
| K925283 | intramed laboratories | VALVULOTOME | February 10, 1994 |
| K932009 | vascutech | THE SAMUELS RETROGRAD VALVULOTOME | September 21, 1993 |
| K930011 | uresil | URESIL VALVE CUTTER WITH INTERCHANGEABLE HEADS | May 26, 1993 |
| K924171 | vascutech | LEMAITRE RETROGRADE VALVULOTOME | February 16, 1993 |
| K924075 | endovascular | DISPOSABLE OPTICAL VALVULOTOME | February 8, 1993 |
| K914385 | intramed laboratories | OPTICAL VALVULOTOME | March 2, 1992 |