2.0MM Expandable Lemaitre Valvulotome (Elv 2.0- GNT)
FDA 510(k) K980723 · Vascutech, Inc.
510(k) numberK980723
Submission
- Device name
- 2.0MM Expandable Lemaitre Valvulotome (Elv 2.0- GNT)
- Applicant
- Vascutech, Inc.
Burlington, MA, US - Received
- February 24, 1998
- Decision date
- February 12, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- MGZ – Valvulotome
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4885
- Specialty
- Cardiovascular
Other 510(k)s with product code MGZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260188 | LimFlow VectorMGZ · Special | LimFlow, Inc. | 03/18/2026SE |
| K250105 | Boomerang Valvulotome (BMGVT080); Boomerang Push Valvulotome (BMGPVT125)MGZ · Traditional | Aveera Medical, Inc. | 07/03/2025SE |
| K221902 | LimFlow VectorMGZ · Traditional | LimFlow, Inc. | 12/21/2022SE |
| K190267 | EZE SIT ValvulotomeMGZ · Traditional | Lemaitre Vascular | 10/30/2019SE |
| K142660 | Antegrade LeMills ValvulotomeMGZ · Special | LeMaitre Vascular, Inc. | 10/17/2014SE |
| K140042 | 1.5MM Hydro Expandable Lemaitre ValvulotomeMGZ · Traditional | LeMaitre Vascular, Inc. | 04/10/2014SE |
| K132047 | Lemills ValvulotomeMGZ · Traditional | LeMaitre Vascular, Inc. | 11/05/2013SE |
| K132190 | Expandable Lemaitre Valvulotome, Over-The-Wire Lemaitre ValvulotomeMGZ · Traditional | LeMaitre Vascular, Inc. | 08/05/2013SE |
| K111884 | Over-The-Wire Expandable Lemaitre ValvulotomeMGZ · Special | LeMaitre Vascular, Inc. | 07/29/2011SE |
| K080178 | Valvulotome by KovenMGZ · Traditional | Koven Technology, Inc. | 07/28/2008SE |
More from Koven Technology, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K001621 | Dardik Carotid ShuntMJN · Traditional | 12/06/2000SE |
| K992942 | Lemaitre Occlusion CatheterMJN · Traditional | 04/13/2000SE |
| K992933 | Lemaitre Irrigation CatheterDXE · Traditional | 03/08/2000SE |
| K992934 | Lemaitre Venous Thrombectomy CatheterDXE · Traditional | 03/01/2000SE |
| K992940 | Lemaitre Balloon Catheter with IrrigationDXE · Traditional | 02/22/2000SE |
| K992941 | Lemaitre Biliary CatheterLQR · Traditional | 01/12/2000SE |
| K992368 | Lemaitre Embolectomy CatheterDXE · Traditional | 12/09/1999SE |
| K946352 | Lemaitre Valvulotome IIMGZ · Traditional | 06/21/1995SE |
| K932009 | The Samuels Retrograd ValvulotomeMGZ · Traditional | 09/21/1993SE |
| K932184 | Sterile Lemaitre Glow 'N Tell TapeKFX · Traditional | 07/22/1993SE |
Questions and answers
When was 2.0MM Expandable Lemaitre Valvulotome (Elv 2.0- GNT) cleared by the FDA?
2.0MM Expandable Lemaitre Valvulotome (Elv 2.0- GNT) (K980723) received a 510(k) decision of Substantially Equivalent on February 12, 1999, 353 days after the submission was received.
What is the product code of K980723?
The FDA product code is MGZ – Valvulotome, a Class II (moderate risk) device regulated under 21 CFR 870.4885.