FDA.reportPublic FDA data

Rene van de Zande

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
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

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