MGZ — Valvulotome Class II
FDA product code MGZ covers "Valvulotome", a Class II medical device regulated under 21 CFR 870.4885. Submissions are reviewed by the Cardiovascular panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |
|---|---|---|---|
| K260188 | limflow | LimFlow Vector | March 18, 2026 |
| 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 |