FDA.reportPublic FDA data

LeMaitre Vascular Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30450425243045042524LeMaitre Vascular Inc.1N2026-01-0147 Dunham Rd Billerica MA US 01821

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3516981155557615K992368LEMAITRE EMBOLECTOMY CATHETERDXE1999-12-09
3516981157571248K970762DUAL LUMEN EMBOLECTOMY CATHETERDXE1997-03-28
3516981792081320K962043AUTO SUTURE MODIFIED VCS CLIP APPLIERFZP1996-09-23
3516981379983299K932184STERILE LEMAITRE GLOW 'N TELL TAPEKFX1993-07-22
3516981991565300K910372INTIMAX THROMBECTOMY CATHETERDXE1991-04-26
3516981919845487K880231MODIFIED PRUITT IRRIGATION & OCCLUSION CATHETERDQT1988-05-25
3516982007929435K872090THE ROBICSEK - PRUITT AORTIC BALLOON OCCLUSION KITDQT1987-10-30
3516981514423274K811276OCCLUSION CATHETERDYG1981-06-30
3516981039176708K212894PhasTIPPDWQ2022-03-31
3516981886707679K202049Python Catheter/Over-the-Wire Latis Graft Cleaning CatheterDXE2021-09-07
3516981614617102K190882XenoSure Biologic PatchPSQ2020-02-13
3516981344805440K190267EZE SIT ValvulotomeMGZ2019-10-30
3516982048338238K183513XenoSure Dura Biologic PatchGXQ2019-06-13
3516981845074673K182916Pruitt F3 Carotid Shunt, 10 Fr, Pruitt F3 Carotid Shunt, 9 Fr, Pruitt F3 Carotid Shunt, 8 FrMJN2018-11-16
3516981595472193K173323AnastoClip GC Closure SystemFZP2018-03-08
3516981105792017K162579VascuCelDXZ2016-10-14
3516981236706634K152833Pruitt F3-S Polyurethane Carotid ShuntMJN2016-01-21
3516981307260398K1400421.5MM HYDRO EXPANDABLE LEMAITRE VALVULOTOMEMGZ2014-04-10
3516981068265664K132047LEMILLS VALVULOTOMEMGZ2013-11-05
3516982072399051K130872CARDIOCELDXZ2014-01-30
3516981188811295K130016LIFESPAN EPTFE VASCULAR GRAFTDSY2013-02-05
3516981259911552K111884OVER-THE-WIRE EXPANDABLE LEMAITRE VALVULOTOMEMGZ2011-07-29
3516982048325696K093231ALBOGRAFT VASCULAR PROSTHESISMAL2010-01-14
3516981692799862K091987ANASTOCLIP MODELS 4001-01, 4000-02, 4000-03, 4000-04, 4004-01, 4004-02, ANASTOCLIPFZP2010-04-23
3516981112196328K071367FLEXCEL CAROTID SHUNT (INLYING), MODEL 2020-05MJN2007-08-29
3516981514581089K051067PRUITT F3 OUTLYING AND INLYING CAROTID SHUNT (WITH AND WITHOUT T-PORT)MJN2005-05-27
3516981101077289K040835PERIPATCH SHEET, MODELS 1.5P8, 1.5P16, 4P4, 4P6, 6P8 AND 10P16FTM2004-06-15
3516981416981724K032041DISTAL PERFUSION CATHETER (1.5 CM) AND (2.5CM)DWF2003-08-27
3516981998224761K022145OVER THE WIRE EMBOLECTOMY CATHETER, MODEL 2302DXE2003-01-14
3516981406668146

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DXE52021-09-07
MGZ42019-10-30
MJN42018-11-16
FZP32018-03-08
DXZ22016-10-14
DQT21988-05-25
DWQ12022-03-31
PSQ12020-02-13
GXQ12019-06-13
DSY12013-02-05
MAL12010-01-14
FTM12004-06-15
DWF12003-08-27
KFX11993-07-22
DYG11981-06-30

PMN#