Disposable Optical Valvulotome
FDA 510(k) K914457 · Nobles-Lai Engineering, Inc.
510(k) numberK914457
Submission
- Device name
- Disposable Optical Valvulotome
- Applicant
- Nobles-Lai Engineering, Inc.
Costa Mesa, CA, US - Received
- October 7, 1991
- Decision date
- February 5, 1992
- 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
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|---|---|---|---|
| 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 |
|---|---|---|
| K953554 | Noblescope Neuroendoscope System & AccessoriesGWG · Traditional | 10/18/1995SE |
| K933345 | Nobles-Lai Endoscopic/LaparoscopicGCJ · Traditional | 02/22/1994SE |
| K920026 | Nobles-Lai Imaging SystemFET · Traditional | 07/28/1992SESK |
| K895688 | Nobles-Lai Engineering Infusion PumpDQI · Traditional | 02/26/1990SE |
Questions and answers
When was Disposable Optical Valvulotome cleared by the FDA?
Disposable Optical Valvulotome (K914457) received a 510(k) decision of Substantially Equivalent on February 5, 1992, 121 days after the submission was received.
What is the product code of K914457?
The FDA product code is MGZ – Valvulotome, a Class II (moderate risk) device regulated under 21 CFR 870.4885.