FDA.reportPublic FDA data

Cardinal Health do Brasil Ltda.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30141010583014101058Cardinal Health do Brasil Ltda.1N2020-04-25Rua Claudio, 74, Agua Branca Sao Paulo Sao Paulo BR 05043-000

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2124061211221650P890017PALMAZ BALLOON EXPANDABLE STENTNIN1991-09-27
2124061867793329K994358ATW MARKER WIRE STEERABLE GUIDEWIREDQX2000-01-13
2124061429762939K994068S.M.A.R.T. NITINOL STENT TRANSHEPATIC BILIARY SYSTEMFGE1999-12-23
2124061214945809K993646S.M.A.R.T. .018 NITINOL STENT TRANSHEPATIC BILIARY SYSTEMFGE1999-11-28
2124061687781849K993091PALMAZ XL TANSHEPATIC BILIARY STENTSFGE1999-10-29
2124061849374960K992673VISTA BRITE TIP CATHETERSDQY1999-10-12
2124061432415401K992347CORDIS SUPER TORQUE MB ANGIOGRAPHIC CATHETER WITH RADIOPAQUE MARKER BANDSDQO1999-10-08
2124061908378715K991673CORDIS TEMPO ANGIOGRAPHY CATHETERDQO1999-05-26
2124061361531283K990530KERLIX MD ANTIMICROBIAL GAUZE DRESSINGNAD2000-01-31
2124061465003195K984500CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEMDYB1998-12-23
2124061561184662K980823CORDIS NITINOL STENT AND DELIVERY SYSTEMFGE1998-12-18
2124061389919682K973619KENDALL CURITY NON-ADHERING DRESSINGKMF1997-12-10
2124061219744908K972978VISTA BRITE TIP GUIDING CATHETERSDQY1997-10-21
2124061265823576K971010PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETERSLIT1997-06-18
2124061700316803K9708545 FR AND 6 FR INFINITI ANGIOGRAPHIC CATHETERDQO1997-09-30
2124061133973332K970392CORDIS AVANTI+CATHETER SHEATH INTRODUCER SYSTEMDRE1997-04-24
2124061295960378K964688LONG MEDIUM PALMAZ-SCHATZ BALLOON EXPANDABLE STENTFGE1997-06-20
2124061687795861K962932CORDIS STABILIZER PLUS XSDQX1996-10-25
2124061226994865K962746CORDIS AVANTI TRANS-RADIAL CATHETER SHEATH INTRODUCER KITDYB1996-10-11
2124061447862224K9609751-4F INFINITI ANGIOGRAPHIC CATHETERDQO1996-04-02
2124061424226738K960632KANGAROO FEEDING TUBE PLACMENT STYLETKNT1996-05-09
2124061199654450K955728CORDIS BILIARY STENTFGE1996-05-08
2124062045018894K954595CORDIS BRITE TIP SHEATH INTRODUCERDYB1995-12-28
2124061410904504K954429KANGAROO ENTRISTAR SKIN-LEVEL GASTROSTOMY KITKNT1996-03-08
2124061135286935K953760CORDIS WIZDOM STEERABLE GUIDEWIREDQX1995-11-07
2124061479934668K952945AQUAFLO HYDROGEL WOUND DRESSING & PACKERNAE1995-08-23
2124061386553081K943636CURADERM ALGINATE HYDROCOLLOIDKMF1994-10-03
2124061055013909K943073CURAFIL WOUND GEL DRESSINGMGQ1994-07-26
2124061134769465K941814ARGYLE DUAL LUMEN UMBILICAL VESSEL CATHETERFOS1994-09-30
2124061590497576K941229ONTRAC STEERABLE GUIDEWIREDQX1994-05-12
2124061281027136K935170CARDIOVASCULAR AND VASCULAR GUIDEWIRE MODIFICATIONSDQX1994-03-31
2124061510856336K933689MODIFICATION OF KENDALL CURASORB CALCIUM ALGINATE WOUND DRESSINGKMF1993-12-13
2124061426742463K932295NON-BALLOON REPLACEMENT GASTROSTOMY KITKNT1994-09-08
2124061997818263K930091CORDIS REFLEX STEERABLE GUIDEWIREDQX1993-04-07
2124061523852828K914007CORDIS 5.2 FRENCH SUPER TORQUE PLUS CARDIO CATHDQO1991-10-18
2124061382492356K833621ENTRI FLEX FEEDING TUBEKNT1983-11-28
2124061060160838K810849CORDIS BIOPSY FORCEPSDWZ1981-04-17
2124061338407854K781357T.E.D. SEQUENTIAL COMPRESSION SLEEVESJOW1978-09-20
2124061149359413K181592RAIN Sheath TransradialDYB2018-08-15
2124061984918014K150836OUTBACK Elite Re-Entry CatheterPDU2015-04-29
2124061172640757K150187ELITECROSS Support CatheterPDU2015-05-19
2124061269942844K143412ADROIT Guiding CatheterDQY2015-01-14
2124061084826144K140286OPTEASE VENA CAVA FILTER AND OPTEASE RETRIEVAL CATHTETERDTK2014-03-07
2124061995513270K133843SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY DILATATION CATHETERLIT2014-06-27
2124061869225451K132567ARGYLE PERIPHERALLY INSERTED CENTRAL CATHETER SINGLE LUMEN, ARGYLE PERIPHERALLY INSERTED CENTRAL CATHETER DUAL LUMENLJS2013-11-05
2124061534018110K130981FLEXSTENT BILIARY SELF EXPANDING STENT SYSTEM; S.M.A.R.T. RE-FLEX BILIARY ELF-EXPANDING STENT SYSTEMFGE2014-03-12
2124061231801124K130725MODIFIED ARGYLE POLYURETHANE UMBILICAL VESSEL CATHETER 2.5FR, 3.5FR, 5 FR.FOS2013-04-17
2124061551598001K121442POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETERLIT2012-06-14
2124061576705666K121125FLEXSTENT BILIARY SELF-EXPANDING STENT SYSTEMFGE2012-07-06
2124061452047761K112797POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETERLIT2012-05-04
2124061804552671K112511DOBBHOFF DUAL PORT FEEDING TUBEKNT2012-05-11
2124061119460794K110133EMPIRA RX PTCA DILATATION CATHETER, EMPRIA NC RX PTCA DILATATION CATHETERLOX2011-06-10
2124061188758493K102035SLEEK OTW PTA CATHETERSLIT2010-12-01
2124061126127219K101651ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE, ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRENTE2010-07-09
2124061038532849K083814OUTBACK LTD RE-ENTRY CATHETER, MODEL: OTB42120PDU2009-01-13
2124061032356958K082143MICRO GUIDE CATHETER XPPDU2008-08-25
2124061322910262K072947SAVVY LONG AND SLEEK PERIPHERAL TRANSLUMINAL ANGIOPLASTY (PTA) CATHETERSLIT2008-02-08
2124061460256836K071189CORDIS AVIATOR PLUS PTA BALLOON DILATATION CATHETERLIT2007-05-16
2124061593385689K062798SMART NITINOL SELF-EXPANDING STENT, MODEL C06120MB, C07120MB, C08120MB, C06150MB, C07150MB, C08150MBFGE2008-02-06
2124062005004281K060877PALMAZ BLUE .014 TRANSHEPATIC BILIARY STENT SYSTEM-MODEL PB1550,BAS,BAX,PB1560,BAS,BAX,PB1850,BAS,BAXPB1860BAS,BAXFGE2006-04-27
2124061938407796K042969MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEMFGE2004-11-08
2124061464635965K041796PRECISE RX NITINOL STENT TRANSHEPATIC BILIARY SYSTEMFGE2004-08-03
2124061693414143K040649KENDALL SCD EXPRESS KAMBIA THIGH LENGTH TEARAWAY SLEEVEJOW2004-07-15
2124061798473935K040511SCD EXPRESS PORTABLE COMPRESSION SYSTEMJOW2004-06-28
2124061145730017K040413CORDIS PALMAZ BLUE TRANSHEPATIC BILIARY STENT ON SLALOM .018 DELIVERY SYSTEMFGE2004-06-21
2124061457588286K040196KENDALL EPUMP ENTERAL FEEDING PUMP AND ENTERAL FEEDING SETSLZH2004-05-05
2124061141094911K033535LUMEND FRONTRUNNER CTO CATHETER AND ACCESSORIESPDU2004-01-07
2124061418281011K033394CORDIS PALMAZ GENESIS TRANSHEPATIC BILLARY STENT ON OPTA PRO .035 DELIVERY SYSTEMFGE2003-12-22
2124061542735615K032737CORDIS POWERFLEX EXTREME PTA BALLOON CATHETER, CORDIS POWERFLEX PLUS PTA BALLOON CATHETER, CORDIS POWERFLEX P3 PTADQY2003-10-02
2124061948135548K032457MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEMFGE2003-09-04
2124061315351496K032137PRECISE RX NITINOL STENT TRANSHEPATIC BILIARY SYSTEMFGE2003-09-17
2124061043835399K031777MODEIFICATION TO: SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEMFGE2003-07-07
2124061866759427K031197MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEMFGE2003-06-16
2124061280857060K030409SMART NITINOL STENT ENDOSCOPIC BILIARY SYSTEMFGE2003-03-10
2124061273561573K023217MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEMFGE2002-10-25
2124061468348945K021898SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEMFGE2002-08-14
2124061246395527K021593MODIFICATION TO ENVOY AND VISTA BRITE TIPDQY2002-06-13
2124061099488383K021345MODIFICATION TO CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON SLALOM .018 DELIVERY SYSTEMFGE2002-06-28
2124061659058516K020809MODIFICATION TO CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENTFGE2002-04-12
2124061393781215K020316CORDIS TRAPEASE PERMANENT VENA CAVA FILTER WITH THE VISEASE ANGIOGRAPHIC VESSEL DILATOR; MODELS 466-P306AU & 466-P306BUDQO2002-03-20
2124061021256362K020052SMART NITINOL STENT TRANSHEPATIC BILIARY SYSTEMFGE2002-02-11
2124061367453827K012993MODIFICATION TO PRECISE NITINOL STENT TRANSHEPATIC BILIARY SYSTEMFGE2001-10-05
2124061815986380K012590CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON OPTA PRO .035 DELIVERY SYSTEMFGE2001-09-07
2124061171061030K012090CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENTFGE2001-08-01
2124061287899860K012087CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENTFGE2001-08-01
2124061558884723K012056CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON SLALOM .018 DELIVERY SYSTEMFGE2001-08-01
2124061126890927K011941EXCILON AMD ANTIMICROBIAL SPONGE MODEL #7088FRO2001-08-22
2124061595839740K011905SNIPER ELITE MODEL-OR-E3872XX SERIESDQX2001-08-28
2124061962447377K010445PRECISE NITINOL STENT TRANSHEPATIC BILLARY SYSTEMFGE2001-03-16
2124061282732990K003365S.M.A.R.T NITINOL STENT ENDOSOPIC BILLARY SYSTEM (VARIOUS)FGE2000-11-22
2124062065152157K003336MODIFICATION TO S.M.A.R.T NITINOL STENT TRANSHEPATIC BILIARY SYSTEMFGE2000-11-22
2124062015986831K001843S.M.A.R.T. NITINOL STENT TRANSHEPATIC BILIARY SYSTEMFGE2000-07-18
2124061378014120K001258BX TRANSHEPATIC BILIARY STENT AND DELIVERY SYSTEMFGE2000-06-27
2124061618645003K001136CORDIS INTRODUCER GUIDEDQY2000-04-28
2124061228163393K000715ENVOY AND VISTA BRITE TIPDQY2000-03-31
2124061055521395K000564CORDIS MEDIUM PALMAZ TRANSHEPATIC BILIARY STENT & DELIVERYFGE2000-03-23
2124061382745744
2124061416850367
2124062024353794

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FGE352014-03-12
DQY72015-01-14
LIT72014-06-27
DQX72001-08-28
DQO62002-03-20
PDU52015-05-19
KNT52012-05-11
DYB42018-08-15
JOW32004-07-15
KMF31997-12-10
FOS22013-04-17
DTK12014-03-07
LJS12013-11-05
LOX12011-06-10
NTE12010-07-09
LZH12004-05-05
FRO12001-08-22
NAD12000-01-31
DRE11997-04-24
NAE11995-08-23
MGQ11994-07-26
NIN11991-09-27
DWZ11981-04-17