Lemaitre Valvulotome II
FDA 510(k) K946352 · Vascutech, Inc.
510(k) numberK946352
Submission
- Device name
- Lemaitre Valvulotome II
- Applicant
- Vascutech, Inc.
North Andover, MA, US - Received
- December 30, 1994
- Decision date
- June 21, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MGZ – Valvulotome
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4885
- Specialty
- Cardiovascular
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| 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 |
| K980723 | 2.0MM Expandable Lemaitre Valvulotome (Elv 2.0- GNT)MGZ · Traditional | 02/12/1999SE |
| 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 Lemaitre Valvulotome II cleared by the FDA?
Lemaitre Valvulotome II (K946352) received a 510(k) decision of Substantially Equivalent on June 21, 1995, 173 days after the submission was received.
What is the product code of K946352?
The FDA product code is MGZ – Valvulotome, a Class II (moderate risk) device regulated under 21 CFR 870.4885.