FDA.reportPublic FDA data

Valvulotome

Definition
A hand-held manual surgical instrument designed for cutting an anatomical valve or valves in situ (e.g., to slit a heart valve or to cut the valves within a vein to allow blood flow in the opposite direction). It is typically a flexible, plastic-coated metal shaft with a proximal handle and an extremely sharp cutting edge at the distal tip (e.g., the distal tip may terminate in a blade which is curved at 90 degrees to the shaft, or an assembly of several thin helicoidal blades that are rotated). This is a reusable device.
GUDID devices
65
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
04953170047671VALVULOTOME (DETACHABLE TYPE)OLYMPUS MEDICAL SYSTEMS CORP.C-0103B2016-09-21
04953170047695VALVULOTOME (DETACHABLE TYPE)OLYMPUS MEDICAL SYSTEMS CORP.C-0104B2016-09-21
14026704927811PILLINGTELEFLEX INCORPORATEDIPN0055762025-09-30
14026704927828PILLINGTELEFLEX INCORPORATEDIPN0055802025-09-30
24026704518863PILLINGTELEFLEX INCORPORATEDIPN0055772018-09-15
24026704518870PILLINGTELEFLEX INCORPORATEDIPN0055782018-09-15
24026704518887PILLINGTELEFLEX INCORPORATEDIPN0055792018-09-15
24026704518900PILLINGTELEFLEX INCORPORATEDIPN0055812018-09-15
24026704518917PILLINGTELEFLEX INCORPORATEDIPN0055822018-09-15
24026704518924PILLINGTELEFLEX INCORPORATEDIPN0055832018-09-15
00194613032715MSI Precision Specialty InstrumentsMed Saver, Inc.421634J2025-08-01
G453332786800PEAK MEDICALPeak Medical Distribution Inc.3327-86802023-05-01
M944AL103010Wexler Surgical, Inc.WEXLER SURGICAL, INC.AL1030.12016-12-19
M944AL103110Wexler Surgical, Inc.WEXLER SURGICAL, INC.AL1031.12016-12-20
04046964567254AESCULAPAESCULAP, INC.MB360R2020-05-08
00840663100095Expandable LeMaitre ValvulotomeLemaitre Vascular, Inc.1000-902015-06-30
00840663100101Expandable LeMaitre ValvulotomeLemaitre Vascular, Inc.e1000-902015-06-30
00840663100118Expandable LeMaitre ValvulotomeLemaitre Vascular, Inc.1000-952015-06-30
00840663100132Over-the-Wire LeMaitre ValvulotomeLemaitre Vascular, Inc.1005-002015-06-30
00840663100149Over-the-Wire LeMaitre ValvulotomeLemaitre Vascular, Inc.e1005-002015-06-30
00840663100163Over-the-Wire LeMaitre ValvulotomeLemaitre Vascular, Inc.1006-002015-06-30
00840663100309Expandable LeMaitre ValvulotomeLemaitre Vascular, Inc.1096-002015-06-30
00840663106653HYDRO LeMaitre ValvulotomeLemaitre Vascular, Inc.1009-002015-06-30
00840663106660HYDRO LeMaitre ValvulotomeLemaitre Vascular, Inc.1010-002015-06-30
00840663106721Expandable LeMaitre ValvulotomeLemaitre Vascular, Inc.e1096-002015-07-15
00840663106820Hydro LeMaitre ValvulotomeLemaitre Vascular, Inc.e1009-002015-07-15
00840663106837Hydro LeMaitre ValvulotomeLemaitre Vascular, Inc.e1010-002015-07-15
00840663107315Retrograde LeMills ValvulotomeLemaitre Vascular, Inc.1050-002015-06-30
00840663107322Antegrade LeMills ValvulotomeLemaitre Vascular, Inc.1050-012015-06-30
00840663107339Antegrade and Retrograde LeMills ValvulotomeLemaitre Vascular, Inc.1050-022015-06-30
00840663107346Retrograde LeMills ValvulotomeLemaitre Vascular, Inc.e1050-002015-06-30
00840663107353Antegrade LeMills ValvulotomeLemaitre Vascular, Inc.e1050-012015-06-30
00840663107360Antegrade and Retrograde LeMills ValvulotomeLemaitre Vascular, Inc.e1050-022015-06-30
10885403035562V. MuellerSTERIS CORPORATIONCH86802020-04-15
10885403035579V. MuellerSTERIS CORPORATIONCH8680-0012020-04-15
10885403035586V. MuellerSTERIS CORPORATIONCH86812020-04-15
24026704518757PILLINGTELEFLEX INCORPORATEDIPN0055662018-09-15
24026704518788PILLINGTELEFLEX INCORPORATEDIPN0055692018-09-15
24026704518795PILLINGTELEFLEX INCORPORATEDIPN0055702018-09-15
24026704518801PILLINGTELEFLEX INCORPORATEDIPN0055712018-09-15
24026704518818PILLINGTELEFLEX INCORPORATEDIPN0055722018-09-15
24026704518825PILLINGTELEFLEX INCORPORATEDIPN0055732018-09-15
04026704518869PILLINGTELEFLEX INCORPORATEDIPN0055772018-09-15
04026704518876PILLINGTELEFLEX INCORPORATEDIPN0055782018-09-15
04026704518883PILLINGTELEFLEX INCORPORATEDIPN0055792018-09-15
04026704518906PILLINGTELEFLEX INCORPORATEDIPN0055812018-09-15
04026704518913PILLINGTELEFLEX INCORPORATEDIPN0055822018-09-15
04026704518920PILLINGTELEFLEX INCORPORATEDIPN0055832018-09-15
24026704518856PILLINGTELEFLEX INCORPORATEDIPN0055762018-09-15
24026704518894PILLINGTELEFLEX INCORPORATEDIPN0055802018-09-15
04057034015308Valvulotome 25cm, blade 2mm, w/ballGeister Medizintechnik GmbH03-75052016-09-21
04057034015322Valvulotome 23cm, blade 2mm, w/ballGeister Medizintechnik GmbH03-75102016-09-21
14953170047678VALVULOTOME (DETACHABLE TYPE)OLYMPUS MEDICAL SYSTEMS CORP.C-0103B2016-09-21
14953170047692VALVULOTOME (DETACHABLE TYPE)OLYMPUS MEDICAL SYSTEMS CORP.C-0104B2016-09-21
00846159010978SCANLAN® In Situ Valvulotomes SCANLAN INTERNATIONAL INC9009-1212016-09-02
00846159010985SCANLAN® In Situ Valvulotomes SCANLAN INTERNATIONAL INC9009-1222016-09-02
00846159010992SCANLAN® In Situ Valvulotomes SCANLAN INTERNATIONAL INC9009-1232016-09-02
00846159031997SCANLAN® In Situ Valvulotomes SCANLAN INTERNATIONAL INC9009-1242016-09-02
00846159032000SCANLAN® In Situ Valvulotomes SCANLAN INTERNATIONAL INC9009-1252016-09-02
00887482049938Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.55-86802018-09-25
00887482049945Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.55-86812018-09-25
00887482049952Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.55-86822018-09-25
00887482049969Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.55-86832018-09-25
00887482090282Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.55-86842018-09-25
00887482090299Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.55-86852018-09-25