Cordis US Corp.

Matched from indexed company URL: CORDIS CORPORATION

FDA Registration(s)

Registration	FEI	Name	Status	Initial importer	Expiration year	Address
1016427	1016427	Cordis US Corp.	1	Y	2026-01-01	14201 N.W. 60TH AVE. Miami Lakes FL US 33014
3004939290	3010142363	Cordis US Corp.	1	N	2026-01-01	5452 Betsy Ross Dr Santa Clara CA US 95054
3025149222	3025149222	Cordis US Corp.	1	Y	2026-01-01	4080 Executive Drive Suite 100 Southaven MS US 38672

Registered Device Listings

Registration key	Listing key	Premarket submission	Device	Product code	Decision date
17	1451029377	P890017	PALMAZ BALLOON EXPANDABLE STENT	NIN	1991-09-27
17	1926315885	P220004	PALMAZ MULLINS XD Pulmonary Stent	QWC	2023-07-21
17	1442911606	P170008	EluNIR Ridaforolimus Eluting Coronary Stent System	NIQ	2017-11-28
17	1673148225	P150002	INCRAFT(R) AAA STENT GRAFT SYSTEM	MIH	2018-11-27
17	1377667471	P120002	SMA RT CONTROL AND SMART VASCULAR STENT SYSTEMS	NIP	2012-11-07
17	1094510370	P110004	PRESILLION PLUS COCR CORONARY STENT RX SYSTEM	MAF	2012-04-12
17	1943565037	P100013	CORDIS EXOSEAL VASCULAR CLOSURE DEVICE	MGB	2011-05-19
61894	1639938592	P040044	MATRIX VASCULAR CLOSURE SYSTEM (VSG)	MGB	2005-08-17
17	1939245623	P040044	MATRIX VASCULAR CLOSURE SYSTEM (VSG)	MGB	2005-08-17
17	1797873423	P030047	CORDIS PRECISE NITINOL STENT SYSTEM	NIM	2006-09-22
17	1221675981	P020036	S.M.A.R.T. AND S.M.A.R.T. CONTROL NITINOL STENT SYSTEM	NIO	2003-08-12
17	1973209253	P020026	CYPHER SIROLIMUS-ELUTING CORONARY STENT ON THE RAPTOR OVER-THE-WIRE DELIVERY SYSTEM OR RAPTORRAIL RAPID EXCHANGE DELIVER	NIQ	2003-04-24
17	1374538442	K994358	ATW MARKER WIRE STEERABLE GUIDEWIRE	DQX	2000-01-13
17	1129102376	K994068	S.M.A.R.T. NITINOL STENT TRANSHEPATIC BILIARY SYSTEM	FGE	1999-12-23
17	1053970951	K993720	CORDIS MAXI LD LARGE DIAMETER BALLOON DILATATION CATHETER	KNQ	2000-01-18
17	1350368244	K993646	S.M.A.R.T. .018 NITINOL STENT TRANSHEPATIC BILIARY SYSTEM	FGE	1999-11-28
17	1705919937	K993091	PALMAZ XL TANSHEPATIC BILIARY STENTS	FGE	1999-10-29
17	1061757465	K992825	CORDIS EXTREME PTA BALLOON CATHETER	LIT	1999-09-15
17	1123554082	K992673	VISTA BRITE TIP CATHETERS	DQY	1999-10-12
17	1941396980	K992347	CORDIS SUPER TORQUE MB ANGIOGRAPHIC CATHETER WITH RADIOPAQUE MARKER BANDS	DQO	1999-10-08
17	2027694760	K991811	CORDIS MAXI DS PTA BALLOON CATHETER	LIT	1999-06-15
17	1535822278	K991673	CORDIS TEMPO ANGIOGRAPHY CATHETER	DQO	1999-05-26
17	1895432872	K984500	CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM	DYB	1998-12-23
17	1387963507	K983023	MODIFICATION TO CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM	DYB	1998-10-01
17	1358080694	K982770	6F ENVOY GUIDING CATHETER	DQY	1998-08-18
17	1564797914	K982632	ENVOY AND VISTA BRITE TIP	DQY	1998-08-18
17	1513057434	K981407	OPTA LP PTA BALLOON CATHETER/POWERFLEX PLUS PTA BALLOON CATHETER	LIT	1998-05-20
17	1676980042	K980823	CORDIS NITINOL STENT AND DELIVERY SYSTEM	FGE	1998-12-18
17	1447214545	K974560	CORDIS VANGUARD STEERABLE GUIDEWIRES	DQX	1998-05-11
17	1296005565	K974448	CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM	DYB	1998-02-06
17	1750139873	K973401	TEMPO 4 ANGIOGRAPHY CATHETER (VARIOUS)	DQO	1997-11-18
17	1549406005	K972978	VISTA BRITE TIP GUIDING CATHETERS	DQY	1997-10-21
17	1720318447	K971646	4F NYLEX ANGIOGRAPHY CATHETER/5F NYLEX ANGIOGRAPHY CATHETER	DQO	1997-07-14
17	1400106270	K971608	CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM	DYB	1997-07-21
17	1919944744	K971572	VISTA BRITE TIP CATHETERS	DQY	1997-07-14
17	1937191959	K971010	PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETERS	LIT	1997-06-18
17	1753422548	K970854	5 FR AND 6 FR INFINITI ANGIOGRAPHIC CATHETER	DQO	1997-09-30
17	1065981560	K970392	CORDIS AVANTI+CATHETER SHEATH INTRODUCER SYSTEM	DRE	1997-04-24
17	2037428869	K965247	ENVOY GUIDING CATHETER	DQY	1997-07-23
17	1068480928	K965211	VISTA BRITE TIP CATHETERS	DQY	1997-03-11
17	1905488304	K964688	LONG MEDIUM PALMAZ-SCHATZ BALLOON EXPANDABLE STENT	FGE	1997-06-20
17	1351741230	K963962	VISTA BRITE TIP CATHETERS	DQY	1997-05-07
17	1180398469	K963214	CORDIS ST STEERABLE GUIDEWIRE	DQX	1996-11-13
17	1051699094	K963171	CINCH QR SGW EXTENSION	DQX	1996-11-07
17	1018556092	K963000	MAXI LD PTA BALLOON CATHETER	LIT	1997-02-20
17	1883787051	K962932	CORDIS STABILIZER PLUS XS	DQX	1996-10-25
17	1474014087	K962830	VISTA BRITE TIP CATHETERS	DQY	1996-10-17
17	1516627886	K962765	CORDIS MARKER WIRE STEERABLE GUIDEWIRE (STABILIZER WITH RADIOPAQUE MARKERS) AND (WIZDOM WITH RADIOPAQUE MARKERS)	DQX	1997-02-21
17	1890153802	K962759	4F NYLEX ANGIOGRAPHIC CATHETER	DQO	1996-10-10
17	1909928345	K962746	CORDIS AVANTI TRANS-RADIAL CATHETER SHEATH INTRODUCER KIT	DYB	1996-10-11
17	1358273263	K962362	CORDIS ENVOY & VISTA BRITE TIP GUIDING CATHETERS	DQY	1996-08-08
17	1132003613	K960975	1-4F INFINITI ANGIOGRAPHIC CATHETER	DQO	1996-04-02
17	1968663730	K955728	CORDIS BILIARY STENT	FGE	1996-05-08
17	1671512063	K954595	CORDIS BRITE TIP SHEATH INTRODUCER	DYB	1995-12-28
17	1836397397	K953760	CORDIS WIZDOM STEERABLE GUIDEWIRE	DQX	1995-11-07
17	1450466118	K952185	CORDIS BRITE TIP, ENVOY GUIDING CATHETER	DQY	1995-08-02
17	1509337854	K952067	CORDIS STEERABLE GUIDEWIRE	DQX	1995-07-20
17	1330639554	K950316	CORDIS STEERABLE GUIDEWIRES	DQX	1995-04-14
17	1045472743	K945616	CORDIS AVANTI CATHETER SHEATH INTRODUCER	DYB	1995-03-29
17	1523990084	K945524	CORDIS INTRODUCING CATHETER	DYB	1995-04-26
17	1579660990	K943340	CORDIS STEERABLE GUIDEWIRE	DQX	1994-09-16
17	1644348551	K942094	CORDIS SAVVY PTA BALLOON CATHETER	LIT	1994-11-01
17	1107805748	K941229	ONTRAC STEERABLE GUIDEWIRE	DQX	1994-05-12
17	1376731959	K935170	CARDIOVASCULAR AND VASCULAR GUIDEWIRE MODIFICATIONS	DQX	1994-03-31
17	1125721449	K933235	CORDIS BIPAL 7 /BIOPSY & BIPAL BIOPSY FORCEPS, MODIF	DWZ	1994-01-06
17	1339742832	K932788	CORDIS BIPAL 7 BIOPSY FORCEPS WITH A INLINE HANDLE	DWZ	1993-09-01
17	1594675084	K932733	CORDIS CATHETER SHEATH INTRODUCER	DYB	1993-08-26
17	1424051656	K930479	NYLEX CATHETERS	DQO	1993-04-21
17	1708574020	K930091	CORDIS REFLEX STEERABLE GUIDEWIRE	DQX	1993-04-07
17	1896237496	K925833	CORDIS STEERABLE GUIDEWIRE	DQX	1993-02-12
17	1801524390	K923134	CORDIS STEERABLE GUIDEWIRE	DQX	1992-10-26
17	1094283458	K920289	CORDIS BIPAL 7 BIOPSY FORCEPS	DWZ	1992-03-30
17	1416891307	K915836	CORDIS 5.0 FRENCH SUPER TORQUE CATHETERS	DQO	1992-02-11
17	1217747274	K914863	CORDIS CINCH(R) STEERABLE GUIDEWIRE EXT W/SLX COAT	DQX	1991-12-18
17	1805764064	K914567	CORDIS BIPAL BIOPSY FORCEPS	DWZ	1991-12-18
17	1090910600	K914352	CORDIS OBTURATOR	DYB	1991-11-22
17	1365438354	K914138	ONTRAC	DQX	1991-12-13
17	1875904449	K914007	CORDIS 5.2 FRENCH SUPER TORQUE PLUS CARDIO CATH	DQO	1991-10-18
17	1285030563	K913801	CORDIS CATH SHEATH INTRO SYST PLUS W/UNISTASIS VAL	DYB	1991-10-16
17	1644296894	K911794	CATH SHEATH INTRODUCER SYST PLUS W/UNISTASIS VALVE	DYB	1991-07-19
17	1971443320	K905423	CORDIS REFLEX STEERABLE GUIDEWIRE	DQX	1991-03-01
17	1259610950	K902612	CORDIS CINCH(TM) STEER GUIDEWIRE EXTEN W/SLX COAT	DQX	1990-12-03
17	1650891323	K894633	CORDIS STEERABLE COATED GUIDEWIRE	DQX	1989-10-17
17	1183843371	K873403	CORDIS STEERABLE GUIDEWIRE	DQX	1988-03-22
17	1582238836	K862975	MODIFIED PTCA GUIDING CATHETERS	DQY	1986-09-23
17	1807231463	K862006	STAND & HIGH FLOW FEMORAL-VENTRICULAR PIGTAIL CATH	DQO	1986-06-27
17	1519318316	K861082	CORDIS CATH SHEATH INTRODUC/MID-LENGTH SHEATH SYST	DYB	1986-05-05
17	1545650158	K854576	MODIFIED CORDIS PTCA GUIDING CATHETERS	DQO	1986-02-26
17	1659106600	K851947	PTCA GUIDING CATHETER	DYB	1985-08-16
17	1997862402	K844161	PTCA GUIDING CATHER	DQO	1985-01-02
17	1321844067	K812231	INTRAVENOUS ADMINISTRATION SET	FPA	1981-08-20
17	1079759705	K810849	CORDIS BIOPSY FORCEPS	DWZ	1981-04-17
17	2020772065	K233637	Cordis BRITECROSS Support Catheter	DQY	2024-06-28
17	1476533466	K232578	VASSALLO GT 018 G12; VASSALLO GT 018 G30	DQX	2023-10-11
17	1777008886	K232574	VASSALLO GT Crossing14	DQX	2023-10-11
17	1477130011	K232573	INFINITI Ambi Angiographic Catheter	DQO	2023-11-21
17	1037529483	K230704	RAIN Sheath Tibial Pedal Introducer	DYB	2023-04-24
17	1096718059	K223432	Vassallo GT 018 Hybrid	DQX	2023-03-09
17	2037914468	K222631	VASSALLO GT EXT	DQX	2022-10-26
17	1339480366	K221832	SABER .014 PTA Dilatation Catheter; SABERX .014 PTA Dilatation Catheter	LIT	2022-08-22
17	1041544038	K220654	ANGIOGUARD XP Emboli Capture Guidewire, ANGIOGUARD RX Emboli Capture Guidewire	NTE	2022-04-06
17	1585829670	K213949	VASSALLO GT 018 Floppy	DQX	2022-06-30
17	1258595950	K212977	SUPER TORQUE MB Angiographic Catheter with Radiopaque markerbands	DQO	2022-02-17
17	1432310300	K210626	SABER .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter	LIT	2021-04-23
17	1135192477	K203533	VASSALLO GT	DQX	2021-04-21
17	1533330516	K203529	VASSALLO GT Hybrid	DQX	2021-05-04
17	1522527140	K202167	Brite Tip Radianz Guiding Sheath	DYB	2021-02-26
17	1008919058	K201377	SABERX RADIANZ Percutaneous Transluminal Angioplasty Dilatation Catheter	LIT	2020-10-09
17	1199255350	K181836	4F Infiniti Angiographic Catheter, 4F & 5F Nylex Angiography Catheters, 4F & 5F Tempo Angiography Catheters	DQO	2018-08-08
17	1651424905	K181592	RAIN Sheath Transradial	DYB	2018-08-15
17	1126855337	K180081	RAILWAY Sheathless Access System	DYB	2018-04-18
17	1612791798	K151363	Zephyr Vascular Compression Device	DXC	2015-07-31
17	1168674909	K150836	OUTBACK Elite Re-Entry Catheter	PDU	2015-04-29
17	1760570114	K150187	ELITECROSS Support Catheter	PDU	2015-05-19
61894	1082996919	K143613	PaxWire Occlusion Balloon System	MJN	2015-08-14
17	1159640164	K143412	ADROIT Guiding Catheter	DQY	2015-01-14
17	2039131079	K140286	OPTEASE VENA CAVA FILTER AND OPTEASE RETRIEVAL CATHTETER	DTK	2014-03-07

Product Codes Associated With Registrations

Product code	Registration listing records	Latest decision
FGE	36	2014-03-12
DQX	29	2023-10-11
DYB	22	2023-04-24
DQY	19	2024-06-28
DQO	18	2023-11-21
LIT	16	2022-08-22
PDU	6	2015-05-19
DTK	6	2014-03-07
DWZ	5	1994-01-06
MGB	4	2011-05-19
NTE	3	2022-04-06
KNQ	2	2002-12-18
MIH	1	2018-11-27
NIQ	1	2017-11-28
MJN	1	2015-08-14
DXC	1	2015-07-31
NIP	1	2012-11-07
MAF	1	2012-04-12
LOX	1	2011-06-10
NIM	1	2006-09-22
NIO	1	2003-08-12
NIQ	1	2003-04-24
DRE	1	1997-04-24
NIN	1	1991-09-27
FPA	1	1981-08-20

PMA

Cordis® PALMAZ® Balloon-Expandable Stent

2022-12-20

Cordis US Corporation14201 N.w. 60th Avenuemiami Lakes, FL 33014 PMA NumberP890017 Supplement NumberS023 Date Received09/28/2022 Decision Date12/20/2022 Product Codes NIO NIN Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Rea...

Cordis® S.M.A.R.T.® CONTROL® Nitinol Stent Systems, Cordis® S.M.A.R.T.® and S.M.A.R.T.® CONTROL® Vascular Stent Systems,

2022-12-16

Cordis US Corporation14201 N.w. 60th Avenuemiami Lakes, FL 33014 PMA NumberP020036 Supplement NumberS048 Date Received11/21/2022 Decision Date12/16/2022 Product Code NIO Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Proce...

Cordis® PRECISE® Nitinol Stent Systems

2022-12-16

Cordis US Corporation14201 N.w. 60th Avenuemiami Lakes, FL 33014 PMA NumberP030047 Supplement NumberS046 Date Received11/21/2022 Decision Date12/16/2022 Product Code NIM Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Proce...

Cordis® S.M.A.R.T.® CONTROL® and S.M.A.R.T.® Vascular Stent System

2022-12-07

Cordis US Corporation14201 Nw 60th Avenuemiami Lakes, FL 33014 PMA NumberP120002 Supplement NumberS022 Date Received11/07/2022 Decision Date12/07/2022 Product Code NIP Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process...

Cordis® S.M.A.R.T.® CONTROL® Vascular Stent System

2022-12-07

Cordis US Corporation14201 N.w. 60th Avenuemiami Lakes, FL 33014 PMA NumberP020036 Supplement NumberS047 Date Received11/07/2022 Decision Date12/07/2022 Product Code NIO Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Proce...

Cordis® PRECISE® Nitinol Stent System

2022-12-07

Cordis US Corporation14201 N.w. 60th Avenuemiami Lakes, FL 33014 PMA NumberP030047 Supplement NumberS045 Date Received11/07/2022 Decision Date12/07/2022 Product Code NIM Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Proce...

EXOSEAL® Vascular Closure

2022-10-28

Cordis US Corporation14201 N.w. 60th Avenuemiami Lakes, FL 33014 PMA NumberP100013 Supplement NumberS026 Date Received10/21/2022 Decision Date10/28/2022 Product Code MGB Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Proce...

MynxGrip Vascular Closure and two components of Mynx Control Vascular Closure (VCD)

2022-10-27

Cordis US Corporation14201 Nw 60th Avenuemiami Lakes, FL 33014 PMA NumberP040044 Supplement NumberS093 Date Received09/29/2022 Decision Date10/27/2022 Product Code MGB Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process...

MynxGrip Vascular Closure , Mynx Control Vascular Closure (VCD)

2022-06-27

Cordis US Corporation14201 Nw 60th Avenuemiami Lakes, FL 33014 PMA NumberP040044 Supplement NumberS092 Date Received06/02/2022 Decision Date06/27/2022 Product Code MGB Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process...

Cordis PRECISE Nitinol Stent System

2022-04-27

Cordis US Corporation14201 N.w. 60th Avenuemiami Lakes, FL 33014 PMA NumberP030047 Supplement NumberS044 Date Received04/18/2022 Decision Date04/27/2022 Product Code NIM Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Proce...

MYNX Vascular Closure

2022-04-25

Cordis US Corporation14201 Nw 60th Avenuemiami Lakes, FL 33014 PMA NumberP040044 Supplement NumberS091 Date Received03/31/2022 Decision Date04/25/2022 Product Code MGB Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process...

Cordis® PALMAZ® Balloon-Expandable Stent

2022-03-08

Cordis US Corporation14201 N.w. 60th Avenuemiami Lakes, FL 33014 PMA NumberP890017 Supplement NumberS022 Date Received12/08/2021 Decision Date03/08/2022 Product Codes NIN NIO Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Rea...

Cordis® Exoseal® Vascular Closure

2022-03-01

Cordis US Corporation14201 N.w. 60th Avenuemiami Lakes, FL 33014 PMA NumberP100013 Supplement NumberS024 Date Received01/31/2022 Decision Date03/01/2022 Product Code MGB Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Proce...

S.M.A.R.T. RADIANZ Vascular Stent System

2022-02-25

Cordis US Corporation14201 Nw 60th Avenuemiami Lakes, FL 33014 PMA NumberP120002 Supplement NumberS020 Date Received09/01/2021 Decision Date02/25/2022 Product Code NIP Advisory Committee Cardiovascular Clinical TrialsNCT00739102 Supplement Typenormal 180 D...

S.M.A.R.T. RADIANZ Vascular Stent System

2022-02-25

Cordis US Corporation14201 N.w. 60th Avenuemiami Lakes, FL 33014 PMA NumberP020036 Supplement NumberS045 Date Received09/01/2021 Decision Date02/25/2022 Product Code NIO Advisory Committee Cardiovascular Clinical TrialsNCT00739102 Supplement Typenormal 180...

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Cordis US Corp.

FDA Registration(s)

Registered Device Listings

Product Codes Associated With Registrations

PMA

PMN

GUDID