Annulus Valvulotome
FDA 510(k) K912636 · Cardio Source
510(k) numberK912636
Submission
- Device name
- Annulus Valvulotome
- Applicant
- Cardio Source
Malibu, CA, US - Received
- June 14, 1991
- Decision date
- October 18, 1991
- 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 |
|---|---|---|
| K912635 | Annulus Disposable ValvulotomeMGZ · Traditional | 10/18/1991SE |
Questions and answers
When was Annulus Valvulotome cleared by the FDA?
Annulus Valvulotome (K912636) received a 510(k) decision of Substantially Equivalent on October 18, 1991, 126 days after the submission was received.
What is the product code of K912636?
The FDA product code is MGZ – Valvulotome, a Class II (moderate risk) device regulated under 21 CFR 870.4885.