FDA.reportPublic FDA data

Cardinal Health Australia 503 PTY LTD

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30135524123013552412Cardinal Health Australia 503 PTY LTD1N2020-04-25Level 11, 50 Queen Street Melbourne Victoria AU 3000

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2070791211221650P890017PALMAZ BALLOON EXPANDABLE STENTNIN1991-09-27
2070792058995453P120002SMA RT CONTROL AND SMART VASCULAR STENT SYSTEMSNIP2012-11-07
2070791658511794P100013CORDIS EXOSEAL VASCULAR CLOSURE DEVICEMGB2011-05-19
2070791888735201P030047CORDIS PRECISE NITINOL STENT SYSTEMNIM2006-09-22
2070791165875230P020036S.M.A.R.T. AND S.M.A.R.T. CONTROL NITINOL STENT SYSTEMNIO2003-08-12
2070791055213635P020026CYPHER SIROLIMUS-ELUTING CORONARY STENT ON THE RAPTOR OVER-THE-WIRE DELIVERY SYSTEM OR RAPTORRAIL RAPID EXCHANGE DELIVERNIQ2003-04-24
2070791867793329K994358ATW MARKER WIRE STEERABLE GUIDEWIREDQX2000-01-13
2070791429762939K994068S.M.A.R.T. NITINOL STENT TRANSHEPATIC BILIARY SYSTEMFGE1999-12-23
2070791155901996K993720CORDIS MAXI LD LARGE DIAMETER BALLOON DILATATION CATHETERKNQ2000-01-18
2070791214945809K993646S.M.A.R.T. .018 NITINOL STENT TRANSHEPATIC BILIARY SYSTEMFGE1999-11-28
2070791687781849K993091PALMAZ XL TANSHEPATIC BILIARY STENTSFGE1999-10-29
2070791318471545K992825CORDIS EXTREME PTA BALLOON CATHETERLIT1999-09-15
2070791849374960K992673VISTA BRITE TIP CATHETERSDQY1999-10-12
2070791432415401K992347CORDIS SUPER TORQUE MB ANGIOGRAPHIC CATHETER WITH RADIOPAQUE MARKER BANDSDQO1999-10-08
2070791934817138K991811CORDIS MAXI DS PTA BALLOON CATHETERLIT1999-06-15
2070791908378715K991673CORDIS TEMPO ANGIOGRAPHY CATHETERDQO1999-05-26
2070791465003195K984500CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEMDYB1998-12-23
2070791133445292K983023MODIFICATION TO CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEMDYB1998-10-01
2070791629774415K9827706F ENVOY GUIDING CATHETERDQY1998-08-18
2070791520960724K982632ENVOY AND VISTA BRITE TIPDQY1998-08-18
2070791560834009K981407OPTA LP PTA BALLOON CATHETER/POWERFLEX PLUS PTA BALLOON CATHETERLIT1998-05-20
2070791561184662K980823CORDIS NITINOL STENT AND DELIVERY SYSTEMFGE1998-12-18
2070791500332493K974560CORDIS VANGUARD STEERABLE GUIDEWIRESDQX1998-05-11
2070791562868886K974448CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEMDYB1998-02-06
2070791083908913K973401TEMPO 4 ANGIOGRAPHY CATHETER (VARIOUS)DQO1997-11-18
2070791219744908K972978VISTA BRITE TIP GUIDING CATHETERSDQY1997-10-21
2070791585950212K9716464F NYLEX ANGIOGRAPHY CATHETER/5F NYLEX ANGIOGRAPHY CATHETERDQO1997-07-14
2070791670981987K971608CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEMDYB1997-07-21
2070791248937648K971572VISTA BRITE TIP CATHETERSDQY1997-07-14
2070791265823576K971010PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETERSLIT1997-06-18
2070791700316803K9708545 FR AND 6 FR INFINITI ANGIOGRAPHIC CATHETERDQO1997-09-30
2070791133973332K970392CORDIS AVANTI+CATHETER SHEATH INTRODUCER SYSTEMDRE1997-04-24
2070791968159707K965211VISTA BRITE TIP CATHETERSDQY1997-03-11
2070791295960378K964688LONG MEDIUM PALMAZ-SCHATZ BALLOON EXPANDABLE STENTFGE1997-06-20
2070791118592319K963962VISTA BRITE TIP CATHETERSDQY1997-05-07
2070791994192542K963214CORDIS ST STEERABLE GUIDEWIREDQX1996-11-13
2070791750277057K963171CINCH QR SGW EXTENSIONDQX1996-11-07
2070791352003178K963000MAXI LD PTA BALLOON CATHETERLIT1997-02-20
2070791687795861K962932CORDIS STABILIZER PLUS XSDQX1996-10-25
2070791165499347K962830VISTA BRITE TIP CATHETERSDQY1996-10-17
2070791976638881K962765CORDIS MARKER WIRE STEERABLE GUIDEWIRE (STABILIZER WITH RADIOPAQUE MARKERS) AND (WIZDOM WITH RADIOPAQUE MARKERS)DQX1997-02-21
2070792028203938K9627594F NYLEX ANGIOGRAPHIC CATHETERDQO1996-10-10
2070791226994865K962746CORDIS AVANTI TRANS-RADIAL CATHETER SHEATH INTRODUCER KITDYB1996-10-11
2070791787754094K962362CORDIS ENVOY & VISTA BRITE TIP GUIDING CATHETERSDQY1996-08-08
2070791447862224K9609751-4F INFINITI ANGIOGRAPHIC CATHETERDQO1996-04-02
2070791199654450K955728CORDIS BILIARY STENTFGE1996-05-08
2070792045018894K954595CORDIS BRITE TIP SHEATH INTRODUCERDYB1995-12-28
2070791135286935K953760CORDIS WIZDOM STEERABLE GUIDEWIREDQX1995-11-07
2070791310581117K952185CORDIS BRITE TIP, ENVOY GUIDING CATHETERDQY1995-08-02
2070791609607683K952067CORDIS STEERABLE GUIDEWIREDQX1995-07-20
2070791483766554K950316CORDIS STEERABLE GUIDEWIRESDQX1995-04-14
2070791298455396K945616CORDIS AVANTI CATHETER SHEATH INTRODUCERDYB1995-03-29
2070791818092207K945524CORDIS INTRODUCING CATHETERDYB1995-04-26
2070791841026604K943340CORDIS STEERABLE GUIDEWIREDQX1994-09-16
2070791968005097K942094CORDIS SAVVY PTA BALLOON CATHETERLIT1994-11-01
2070791590497576K941229ONTRAC STEERABLE GUIDEWIREDQX1994-05-12
2070791281027136K935170CARDIOVASCULAR AND VASCULAR GUIDEWIRE MODIFICATIONSDQX1994-03-31
2070791538254031K933235CORDIS BIPAL 7 /BIOPSY & BIPAL BIOPSY FORCEPS, MODIFDWZ1994-01-06
2070791417676163K932788CORDIS BIPAL 7 BIOPSY FORCEPS WITH A INLINE HANDLEDWZ1993-09-01
2070791292846810K932733CORDIS CATHETER SHEATH INTRODUCERDYB1993-08-26
2070791887466071K930479NYLEX CATHETERSDQO1993-04-21
2070791997818263K930091CORDIS REFLEX STEERABLE GUIDEWIREDQX1993-04-07
2070791502811888K925833CORDIS STEERABLE GUIDEWIREDQX1993-02-12
2070791142049655K923134CORDIS STEERABLE GUIDEWIREDQX1992-10-26
2070791127561391K920289CORDIS BIPAL 7 BIOPSY FORCEPSDWZ1992-03-30
2070791314921489K915836CORDIS 5.0 FRENCH SUPER TORQUE CATHETERSDQO1992-02-11
2070791462904456K914863CORDIS CINCH(R) STEERABLE GUIDEWIRE EXT W/SLX COATDQX1991-12-18
2070791630274169K914567CORDIS BIPAL BIOPSY FORCEPSDWZ1991-12-18
2070791895196370K914352CORDIS OBTURATORDYB1991-11-22
2070791523852828K914007CORDIS 5.2 FRENCH SUPER TORQUE PLUS CARDIO CATHDQO1991-10-18
2070791986750042K913801CORDIS CATH SHEATH INTRO SYST PLUS W/UNISTASIS VALDYB1991-10-16
2070792017318748K911794CATH SHEATH INTRODUCER SYST PLUS W/UNISTASIS VALVEDYB1991-07-19
2070791875207836K905423CORDIS REFLEX STEERABLE GUIDEWIREDQX1991-03-01
2070791329513310K902612CORDIS CINCH(TM) STEER GUIDEWIRE EXTEN W/SLX COATDQX1990-12-03
2070791352741720K894633CORDIS STEERABLE COATED GUIDEWIREDQX1989-10-17
2070791208970095K873403CORDIS STEERABLE GUIDEWIREDQX1988-03-22
2070791867266503K862975MODIFIED PTCA GUIDING CATHETERSDQY1986-09-23
2070792055469104K862006STAND & HIGH FLOW FEMORAL-VENTRICULAR PIGTAIL CATHDQO1986-06-27
2070791423471923K861082CORDIS CATH SHEATH INTRODUC/MID-LENGTH SHEATH SYSTDYB1986-05-05
2070791240673495K854576MODIFIED CORDIS PTCA GUIDING CATHETERSDQO1986-02-26
2070791772259375K851947PTCA GUIDING CATHETERDYB1985-08-16
2070791543083780K844161PTCA GUIDING CATHERDQO1985-01-02
2070791060160838K810849CORDIS BIOPSY FORCEPSDWZ1981-04-17
2070791984918014K150836OUTBACK Elite Re-Entry CatheterPDU2015-04-29
2070791172640757K150187ELITECROSS Support CatheterPDU2015-05-19
2070791269942844K143412ADROIT Guiding CatheterDQY2015-01-14
2070791084826144K140286OPTEASE VENA CAVA FILTER AND OPTEASE RETRIEVAL CATHTETERDTK2014-03-07
2070791995513270K133843SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY DILATATION CATHETERLIT2014-06-27
2070791962894441K131225ADROIT GUIDING CATHETERDQY2013-05-29
2070791534018110K130981FLEXSTENT BILIARY SELF EXPANDING STENT SYSTEM; S.M.A.R.T. RE-FLEX BILIARY ELF-EXPANDING STENT SYSTEMFGE2014-03-12
2070791551598001K121442POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETERLIT2012-06-14
2070791576705666K121125FLEXSTENT BILIARY SELF-EXPANDING STENT SYSTEMFGE2012-07-06
2070791452047761K112797POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETERLIT2012-05-04
2070791119460794K110133EMPIRA RX PTCA DILATATION CATHETER, EMPRIA NC RX PTCA DILATATION CATHETERLOX2011-06-10
2070791188758493K102035SLEEK OTW PTA CATHETERSLIT2010-12-01
2070791126127219K101651ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE, ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRENTE2010-07-09
2070791624078089K091077OPTEASE VENA CAVA FILTER AND RETRIEVAL CATHETERDTK2010-02-04
2070791038532849K083814OUTBACK LTD RE-ENTRY CATHETER, MODEL: OTB42120PDU2009-01-13
2070792004811016K082580SPECTRA GUIDEWIRE INTRODUCER NEEDLEDYB2008-12-08
2070791032356958K082143MICRO GUIDE CATHETER XPPDU2008-08-25
2070791322910262K072947SAVVY LONG AND SLEEK PERIPHERAL TRANSLUMINAL ANGIOPLASTY (PTA) CATHETERSLIT2008-02-08
2070791460256836K071189CORDIS AVIATOR PLUS PTA BALLOON DILATATION CATHETERLIT2007-05-16
2070791593385689K062798SMART NITINOL SELF-EXPANDING STENT, MODEL C06120MB, C07120MB, C08120MB, C06150MB, C07150MB, C08150MBFGE2008-02-06
2070791505190395K062531ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE AND ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRENTE2006-09-22
2070792005004281K060877PALMAZ BLUE .014 TRANSHEPATIC BILIARY STENT SYSTEM-MODEL PB1550,BAS,BAX,PB1560,BAS,BAX,PB1850,BAS,BAXPB1860BAS,BAXFGE2006-04-27
2070791938407796K042969MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEMFGE2004-11-08
2070791464635965K041796PRECISE RX NITINOL STENT TRANSHEPATIC BILIARY SYSTEMFGE2004-08-03
2070791145730017K040413CORDIS PALMAZ BLUE TRANSHEPATIC BILIARY STENT ON SLALOM .018 DELIVERY SYSTEMFGE2004-06-21
2070791411972442K034050CORDIS OPTEASE VENA CAVA FILTER, MODELS 466-F220A AND 466-F220B; RETRIEVABLE CATHETER, MODEL 466-C220FDTK2004-03-22
2070791141094911K033535LUMEND FRONTRUNNER CTO CATHETER AND ACCESSORIESPDU2004-01-07
2070791418281011K033394CORDIS PALMAZ GENESIS TRANSHEPATIC BILLARY STENT ON OPTA PRO .035 DELIVERY SYSTEMFGE2003-12-22
2070791542735615K032737CORDIS POWERFLEX EXTREME PTA BALLOON CATHETER, CORDIS POWERFLEX PLUS PTA BALLOON CATHETER, CORDIS POWERFLEX P3 PTADQY2003-10-02
2070791948135548K032457MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEMFGE2003-09-04
2070791315351496K032137PRECISE RX NITINOL STENT TRANSHEPATIC BILIARY SYSTEMFGE2003-09-17
2070791043835399K031777MODEIFICATION TO: SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEMFGE2003-07-07
2070791866759427K031197MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEMFGE2003-06-16
2070791280857060K030409SMART NITINOL STENT ENDOSCOPIC BILIARY SYSTEMFGE2003-03-10
2070791193149860K023907CORDIS MAXI LD LARGE DIAMETER BALLOON DILATATION CATHETER, CORDIS MAXI LD PTA BALLOON DILATION CATHETERKNQ2002-12-18
2070791273561573K023217MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEMFGE2002-10-25
2070791468348945K021898SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEMFGE2002-08-14

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FGE352014-03-12
DQX212001-08-28
DQY172015-01-14
DYB172008-12-08
DQO152002-03-20
LIT132014-06-27
DTK62014-03-07
PDU52015-05-19
DWZ51994-01-06
NTE22010-07-09
KNQ22002-12-18
NIP12012-11-07
LOX12011-06-10
MGB12011-05-19
NIM12006-09-22
NIO12003-08-12
NIQ 12003-04-24
DRE11997-04-24
NIN11991-09-27