1.5MM Hydro Expandable Lemaitre Valvulotome
FDA 510(k) K140042 · LeMaitre Vascular, Inc.
510(k) numberK140042
Submission
- Device name
- 1.5MM Hydro Expandable Lemaitre Valvulotome
- Applicant
- LeMaitre Vascular, Inc.
Burlington, MA, US - Received
- January 8, 2014
- Decision date
- April 10, 2014
- 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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| 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 |
| 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 |
| K022823 | Valvulotome, Retrograde : 03-7500- 03-7510, Antegrade 03-7520MGZ · Traditional | Geister Medizin Technik GmbH | 07/01/2004SE |
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| K182916 | Pruitt F3 Carotid Shunt, 10 Fr, Pruitt F3 Carotid Shunt, 9 Fr, Pruitt F3 Carotid Shunt…MJN · Special | 11/16/2018SE |
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| K152833 | Pruitt F3-S Polyurethane Carotid ShuntMJN · Traditional | 01/21/2016SE |
| K143454 | Pruitt F3-S Carotid ShuntMJN · Traditional | 08/27/2015SE |
| K142660 | Antegrade LeMills ValvulotomeMGZ · Special | 10/17/2014SE |
| K133026 | Unballoon Non-Occlusion Modeling CatheterDQY · Traditional | 12/31/2013SE |
Questions and answers
When was 1.5MM Hydro Expandable Lemaitre Valvulotome cleared by the FDA?
1.5MM Hydro Expandable Lemaitre Valvulotome (K140042) received a 510(k) decision of Substantially Equivalent on April 10, 2014, 92 days after the submission was received.
What is the product code of K140042?
The FDA product code is MGZ – Valvulotome, a Class II (moderate risk) device regulated under 21 CFR 870.4885.