ANNULUS VALVULOTOME
FDA 510(k) clearance K912636 · decided 1991-10-18
Clearance details
- K-number
- K912636
- Device name
- ANNULUS VALVULOTOME
- Applicant
- Cardio Source
- Decision
- Substantially Equivalent
- Date received
- 1991-06-14
- Decision date
- 1991-10-18
- Days to decision
- 126 days
- Clearance type
- Traditional
- Product code
- MGZ
- Device class
- 2
- Regulation number
- 870.4885
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Malibu, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| LimFlow Vector (K260188) | LimFlow, Inc. | 2026-03-18 |
| Boomerang Valvulotome (BMGVT080); Boomerang Push Valvulotome (BMGPVT125) (K250105) | Aveera Medical, Inc. | 2025-07-03 |
| LimFlow Vector (K221902) | LimFlow, Inc. | 2022-12-21 |
| EZE SIT Valvulotome (K190267) | Lemaitre Vascular | 2019-10-30 |
| Antegrade LeMills Valvulotome (K142660) | LeMaitre Vascular, Inc. | 2014-10-17 |
| 1.5MM HYDRO EXPANDABLE LEMAITRE VALVULOTOME (K140042) | LeMaitre Vascular, Inc. | 2014-04-10 |
| LEMILLS VALVULOTOME (K132047) | LeMaitre Vascular, Inc. | 2013-11-05 |
| EXPANDABLE LEMAITRE VALVULOTOME, OVER-THE-WIRE LEMAITRE VALVULOTOME (K132190) | LeMaitre Vascular, Inc. | 2013-08-05 |
| OVER-THE-WIRE EXPANDABLE LEMAITRE VALVULOTOME (K111884) | LeMaitre Vascular, Inc. | 2011-07-29 |
| VALVULOTOME BY KOVEN (K080178) | Koven Technology, Inc. | 2008-07-28 |
| VALVULOTOME, RETROGRADE : 03-7500- 03-7510, ANTEGRADE 03-7520 (K022823) | Geister Medizin Technik GmbH | 2004-07-01 |
| FOGARTY VALVULOTOME, MODEL 700091 (K001734) | Edwards Lifesciences, LLC | 2001-03-26 |
Recalls involving this device
No recalls on record reference this clearance.