FDA.reportPublic FDA data

Rene van de Zande

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30115437403011543740Rene van de Zande1N2026-01-0110900 Research Blvd Ste 160c Pmb 2066 Austin TX US 78759
96163793003572251Rene van de Zande1N2020-04-252500 Bee Cave Road Bldg 1, Suite 300 Austin TX US 78746
97104523000157372Rene van de Zande1N2020-04-252500 Bee Cave Road Bldg 1, Suite 300 Austin TX US 78746
30069460753006946075Rene van de Zande1N2020-04-252500 Bee Cave Road Bldg 1, Suite 300 Austin TX US 78746
30075847103007584710Rene van de Zande1N2020-04-252500 Bee Cave Road Bldg 1, Suite 300 Austin TX US 78746
30108062293010806229Rene van de Zande1N2020-04-252500 Bee Cave Road Bldg 1, Suite 300 Austin TX US 78746
30108799433010879943Rene van de Zande1N2020-04-252500 Bee Cave Road Bldg 1, Suite 300 Austin TX US 78746
30115549523011554952Rene van de Zande1N2020-04-252500 Bee Cave Road Bldg 1, Suite 300 Austin TX US 78746

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
201211246174566K990284BAYLIS MEDICAL RF SEPTOSTOMY GENERATOR, NYKANEN RF SEPTOSTOMY CATHETER, BAYLIS MEDICAL CONNECTOR CABLEDXF2001-02-01
201211246690306K972846BMC RF CANNULAGXI1998-07-17
1686401455069142K952442FREEDOM BATHILJ1995-11-02
1686401158830508K930665CENTURY BATHING SYSTEMILJ1995-08-28
201211886516507K190688VersaCross Steerable Sheath, VersaCross Transseptal DilatorDYB2019-04-17
201211588279577K183655VersaCross Transseptal SheathDYB2019-05-20
201212033267303K183649Diagnostic Fixed Electrophysiology Catheter, Diagnostic Electrophysiology CableDRF2019-06-07
201211575676094K183632Diagnostic Fixed Electrophysiology Lumen Catheter , Diagnostic Electrophysiology CableDRF2019-06-07
201212047861354K182064ExpanSure Transseptal Dilation SystemDRE2019-03-21
201211706800453K181864Polaris RF Ablation SystemGXD2019-01-02
201211775706431K161949OsteoCool V-3 RF Ablation SystemGEI2017-01-31
201211853499101K161878PORTAGE SystemHRX2016-09-26
201211048274931K152057OsteoCool V-3 RF Ablation SystemGEI2015-11-24
201211210231142K151009Nexus SutureGAT2015-08-18
201211895455292K150709ProTrack RF Anchor WireDXF2015-06-17
201211322039036K132374BAYLIS MEDICAL RF PERFORATION PROBE V2.0GEI2013-08-30
201211993750467K122926SUREFLEX STEERABLE GUIDING SHEATH KITDYB2013-01-24
201211966514212K122278BAYLIS MEDICAL COMPANY RADIOFREQUENCY PERFORATION GENERATORGEI2012-11-07
201211575745872K111288ANCHORWIRE GUIDEWIREDQX2011-08-02
1686401044913495K110994PARKER 500ILJ2011-07-06
201211571870056K102948TORFLEX TRANSSEPTAL GUIDING SHEATHDYB2011-04-01
201211935355784K101615POWERWIRE RADIOFREQUENCY GUIDEWIREPDU2010-07-28
201211547153073K073326NRG TRANSSEPTAL NEEDLEDXF2008-05-28
201211282126343K023334BMC CATHETER CONNECTOR CABLE, MODEL RFP-101DSA2002-12-31
201211902877639K014075BMC COAXIAL INJECTABLE CATHETER, MODEL CIC 38/145 AND CIC 35/145DQX2002-03-07
201211240603183K013904BMC RADIO FREQUENCY PERFORATION GENERATOR, MODELS RFP-100-115 AND RFP-100-230GEI2002-02-12
201211900903373K010265BAYLIS MEDICAL RF PERFORATION PROBE, MODEL RFP-265GEI2001-04-09
1686401679914813K001079RECUMBENT BATHING SYSTEMS, RHAPSODY AND PRIMOILJ2000-05-01
1686401001257113
159691073297976
1686401090679639
1832541354000119
201211478734201
159691641048900
1713661685414391
159691734149868
1832541747212878
159691823200394
1927271843754872
1832541856731686
975371960848293
1832541967105440
2104281227439517
2104281319530768
2104281396088381
2104281460443772
2104281481683553
2104281506407923
2104281572490222
2104281597101277
2104281755443755
2104281763161790
2104281776745278
2104281912861571
2104281975326882
2104281987092440
2104282001014372
2104282052428153

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GEI62017-01-31
DYB42019-05-20
ILJ42011-07-06
DXF32015-06-17
DRF22019-06-07
DQX22011-08-02
DRE12019-03-21
GXD12019-01-02
HRX12016-09-26
GAT12015-08-18
PDU12010-07-28
DSA12002-12-31
GXI11998-07-17