510(k) K932009
- Device
- THE SAMUELS RETROGRAD VALVULOTOME
- Applicant
- VASCUTECH, INC.
- 510(k) number
- K932009
- Product code
- MGZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1993-09-21
- Date received
- 1993-04-23
- Regulation
- 870.4885
- Classification name
- Valvulotome
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- GEORGE W LEMAITRE
- Address
- 790 Tpke. St. North Andover MA US 01845 01845
FDA Registration Numbers#
- 3003637635
- 2126670
- 3009018440
- 3010041511
- 3010273872
- 3027735872
- 1319639
- 3011137372
- 3023527320
- 8010697
- 1220948
- 3009039068
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code MGZ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260188 | LimFlow Vector | LimFlow, Inc. | 2026-03-18 |
| K250105 | Boomerang Valvulotome (BMGVT080); Boomerang Push Valvulotome (BMGPVT125) | Aveera Medical, Inc. | 2025-07-03 |
| K221902 | LimFlow Vector | LimFlow, Inc. | 2022-12-21 |
| K190267 | EZE SIT Valvulotome | Lemaitre Vascular | 2019-10-30 |
| K142660 | Antegrade LeMills Valvulotome | LeMaitre Vascular, Inc. | 2014-10-17 |
| K140042 | 1.5MM HYDRO EXPANDABLE LEMAITRE VALVULOTOME | LeMaitre Vascular, Inc. | 2014-04-10 |
| K132047 | LEMILLS VALVULOTOME | LeMaitre Vascular, Inc. | 2013-11-05 |
| K132190 | EXPANDABLE LEMAITRE VALVULOTOME, OVER-THE-WIRE LEMAITRE VALVULOTOME | LeMaitre Vascular, Inc. | 2013-08-05 |
| K111884 | OVER-THE-WIRE EXPANDABLE LEMAITRE VALVULOTOME | LeMaitre Vascular, Inc. | 2011-07-29 |
| K080178 | VALVULOTOME BY KOVEN | Koven Technology, Inc. | 2008-07-28 |
| K022823 | VALVULOTOME, RETROGRADE : 03-7500- 03-7510, ANTEGRADE 03-7520 | Geister Medizin Technik GmbH | 2004-07-01 |
| K001734 | FOGARTY VALVULOTOME, MODEL 700091 | Edwards Lifesciences, LLC | 2001-03-26 |
| K980723 | 2.0MM EXPANDABLE LEMAITRE VALVULOTOME (ELV 2.0- GNT) | Vascutech, Inc. | 1999-02-12 |
| K965137 | FOGARTY VALVULOTOME MODEL 700091 | Baxter Edwards | 1997-06-04 |
| K946352 | LEMAITRE VALVULOTOME II | Vascutech, Inc. | 1995-06-21 |
Legacy Summary#
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FDA Review#
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