FDA.reportPublic FDA data

Heart valve sizer, reusable

Definition
A hand-held manual surgical instrument intended to be used during heart valve repair or replacement that enables evaluation of the valve opening (patient annulus) into which the appropriate sized annuloplasty ring or replacement valve will be implanted. It is typically available as a set of sizers in a range for the aortic, mitral, or tricuspid valve, and handles to which the sizers are attached; this handle may also be connected to the valve or ring holder to assist implantation. This is a reusable device intended to be sterilized prior to use.
GUDID devices
92
Last updated
2023-02-27 08:22:39

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
05415067041937NAST. JUDE MEDICAL, INC.RSAR-507A2023-02-17
05415067041951Séguin™ST. JUDE MEDICAL, INC.SAR-5012023-02-17
05415067042330NAST. JUDE MEDICAL, INC.9052023-02-17
00763000318451CG Future™MEDTRONIC, INC.7638S2023-02-05
04058749102697NAFehling Instruments GmbH & Co. KGZDS-62022-11-08
04058749042375NAFehling Instruments GmbH & Co. KGMNV-02022-11-07
04058749042542NAFehling Instruments GmbH & Co. KGMNX-12022-11-07
04058749042559NAFehling Instruments GmbH & Co. KGMNX-22022-11-07
04058749042573NAFehling Instruments GmbH & Co. KGMNX-32022-11-07
04058749042610NAFehling Instruments GmbH & Co. KGMNX-52022-11-07
04058749042627NAFehling Instruments GmbH & Co. KGMNX-62022-11-07
04058749042634NAFehling Instruments GmbH & Co. KGMNX-72022-11-07
04058749042641NAFehling Instruments GmbH & Co. KGMNX-82022-11-07
04058749042658NAFehling Instruments GmbH & Co. KGMNX-92022-11-07
00763000318499Duran AnCore™MEDTRONIC, INC.7620S2022-10-14
04058749042597NAFehling Instruments GmbH & Co. KGMNX-42022-09-14
04058749047295NAFehling Instruments GmbH & Co. KGMSS-1V2022-09-13
04058749047318NAFehling Instruments GmbH & Co. KGMSS-2V2022-09-13
04058749047325NAFehling Instruments GmbH & Co. KGMSS-32022-09-13
00763000318482Contour 3D™MEDTRONIC, INC.7690S2022-07-02
05415067034502Epic™ST. JUDE MEDICAL, INC.E20002021-12-20
00763000414283SimuPlus™MEDTRONIC, INC.7700PS2021-06-28
00763000414290SimuPlus™MEDTRONIC, INC.7700FS2021-06-28
00763000414306SimuForm™MEDTRONIC, INC.7800PS2021-06-28
00763000318529Simulus™MEDTRONIC, INC.7552021-06-25
00763000318512Simulus™MEDTRONIC, INC.7502021-06-06
00763000318536Simulus™MEDTRONIC, INC.7522021-06-06
00763000318543Simulus™MEDTRONIC, INC.8502021-06-06
00763000318550Medtronic Open Pivot™MEDTRONIC, INC.5762021-06-06
00763000318567Simulus™MEDTRONIC, INC.751PS2021-06-06
00763000318574Simulus™MEDTRONIC, INC.851PS2021-06-06
00763000318598Medtronic Open Pivot™MEDTRONIC, INC.5772021-06-06
00763000318604Medtronic Open Pivot™MEDTRONIC, INC.5782021-06-06
00763000318413Hancock™ IIMEDTRONIC, INC.7505SET2021-04-04
00763000318420Hancock™ IIMEDTRONIC, INC.7510SET2021-04-04
08022057013958CARBOMEDICS PROSTHETIC HEART VALVESCORCYM SRLVS-2002021-04-02
08022057013965CARBOMEDICS PROSTHETIC HEART VALVESCORCYM SRLVS2-16182021-04-02
08022057014047CARBOMEDICS SUPRA-ANNULARCORCYM SRLSAS-2002021-04-02
08022057014054CARBOMEDICS ANNULOFLO CARBOMEDICS ANNULOFLEXCORCYM SRLARMI-7002021-04-02
08022057014351MITROFLOWCORCYM SRLICV11902021-04-02
08022057014733PERCEVAL SCORCYM SRLICV12192021-04-02
08022057014894FREEDOM SOLOCORCYM SRLICV12372021-04-02
00763000318338Freestyle™MEDTRONIC, INC.7990SET2021-04-01
00763000318369NAMEDTRONIC, INC.76422021-04-01
00763000318390MOSAIC™MEDTRONIC, INC.73102021-04-01
08022057015143Annuloplasty Ring Sizer SetCORCYM SRLICV13402021-04-01
08022057015303CROWN PRTCORCYM SRLICV13552021-04-01
00763000271558SimuPlus™MEDTRONIC, INC.7700PS2020-07-30
00763000271565SimuPlus™MEDTRONIC, INC.7700FS2020-07-30
00763000271572SimuForm™MEDTRONIC, INC.7800PS2020-07-30
00846159035643SCANLAN® InstrumentationSCANLAN INTERNATIONAL INCQ38042-022020-06-25
00763000334352Simulus™MEDTRONIC, INC.851PS2020-02-23
00643169346192Simulus™MEDTRONIC, INC.751PS2020-01-24
05414734010078SJM™ST. JUDE MEDICAL, INC.Seguin Annuloplasty Ring Sizer Set2015-12-04
05414734010085SJM Tailor™ST. JUDE MEDICAL, INC.TAR-5052015-10-15
05414734010153St Jude Medical™ST. JUDE MEDICAL, INC.Mechanical Heart Valve Sizer Set2015-11-02
05414734021630SJM™ST. JUDE MEDICAL, INC.Rigid Saddle Ring Sizer Set2015-12-04
05414734023856NAST. JUDE MEDICAL, INC.905-232015-11-13
05414734025256NAST. JUDE MEDICAL, INC.905-192015-11-13
05414734025263NAST. JUDE MEDICAL, INC.905-212015-11-13
05414734025270NAST. JUDE MEDICAL, INC.Double-ended handle 25mm sizer rings2015-11-13
05414734025287NAST. JUDE MEDICAL, INC.905-272015-11-13
05414734025294NAST. JUDE MEDICAL, INC.905-292015-11-13
05414734027694St. Jude Medical™ST. JUDE MEDICAL, INC.Bioprosthetic Heart Valve Sizer Set2015-11-02
05414734030991Regent™ST. JUDE MEDICAL, INC.Mechanical Heart Valve Sizer Set2015-12-04
05414734052078Trifecta™ST. JUDE MEDICAL, INC.Valve TF2000 Sizer Set2015-11-13
05415067003898NAST. JUDE MEDICAL, INC.905-172015-11-13
05415067003904NAST. JUDE MEDICAL, INC.905-312015-11-13
05415067003928NAST. JUDE MEDICAL, INC.35mm Standard sizer ring2015-11-13
05415067003935NAST. JUDE MEDICAL, INC.905-372015-11-13
05415067004352Tailor™ & Attune™ST. JUDE MEDICAL, INC.Robotic Sizer2015-10-15
05415067004369Tailor™ & Attune™ST. JUDE MEDICAL, INC.Robotic Sizer2015-10-15
05415067004376Tailor™ & Attune™ ST. JUDE MEDICAL, INC.Robotic Sizer2015-10-15
05415067004383Tailor™ & Attune™ST. JUDE MEDICAL, INC.Robotic Sizer2015-10-15
05415067004390Tailor™ & Attune™ST. JUDE MEDICAL, INC.Robotic Sizer2015-10-15
05415067004406Tailor™ & Attune™ST. JUDE MEDICAL, INC.Robotic Sizer2015-10-15
05415067004413Tailor™ & Attune™ST. JUDE MEDICAL, INC.Robotic Sizer2015-10-15
05415067004420Tailor™ & Attune™ST. JUDE MEDICAL, INC.Robotic Sizer2015-10-15
05415067004437Tailor™ & Attune™ST. JUDE MEDICAL, INC.Robotic Sizer2015-10-15
05415067004444Tailor™ & Attune™ST. JUDE MEDICAL, INC.Robotic Sizer2015-10-15