Linda Ruedy

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
9616099	3003528016	Linda Ruedy	1	N	2026-01-01	5452 Betsy Ross Dr Santa Clara CA US 95054

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
16	1673148225	P150002	INCRAFT(R) AAA STENT GRAFT SYSTEM	MIH	2018-11-27
16	1377667471	P120002	SMA RT CONTROL AND SMART VASCULAR STENT SYSTEMS	NIP	2012-11-07
16	1797873423	P030047	CORDIS PRECISE NITINOL STENT SYSTEM	NIM	2006-09-22
16	1221675981	P020036	S.M.A.R.T. AND S.M.A.R.T. CONTROL NITINOL STENT SYSTEM	NIO	2003-08-12
16	1129102376	K994068	S.M.A.R.T. NITINOL STENT TRANSHEPATIC BILIARY SYSTEM	FGE	1999-12-23
16	1053970951	K993720	CORDIS MAXI LD LARGE DIAMETER BALLOON DILATATION CATHETER	KNQ	2000-01-18
16	1350368244	K993646	S.M.A.R.T. .018 NITINOL STENT TRANSHEPATIC BILIARY SYSTEM	FGE	1999-11-28
16	1061757465	K992825	CORDIS EXTREME PTA BALLOON CATHETER	LIT	1999-09-15
16	1123554082	K992673	VISTA BRITE TIP CATHETERS	DQY	1999-10-12
16	1941396980	K992347	CORDIS SUPER TORQUE MB ANGIOGRAPHIC CATHETER WITH RADIOPAQUE MARKER BANDS	DQO	1999-10-08
16	2027694760	K991811	CORDIS MAXI DS PTA BALLOON CATHETER	LIT	1999-06-15
16	1535822278	K991673	CORDIS TEMPO ANGIOGRAPHY CATHETER	DQO	1999-05-26
16	1358080694	K982770	6F ENVOY GUIDING CATHETER	DQY	1998-08-18
16	1564797914	K982632	ENVOY AND VISTA BRITE TIP	DQY	1998-08-18
16	1513057434	K981407	OPTA LP PTA BALLOON CATHETER/POWERFLEX PLUS PTA BALLOON CATHETER	LIT	1998-05-20
16	1676980042	K980823	CORDIS NITINOL STENT AND DELIVERY SYSTEM	FGE	1998-12-18
16	1296005565	K974448	CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM	DYB	1998-02-06
16	1750139873	K973401	TEMPO 4 ANGIOGRAPHY CATHETER (VARIOUS)	DQO	1997-11-18
16	1549406005	K972978	VISTA BRITE TIP GUIDING CATHETERS	DQY	1997-10-21
16	1720318447	K971646	4F NYLEX ANGIOGRAPHY CATHETER/5F NYLEX ANGIOGRAPHY CATHETER	DQO	1997-07-14
16	1400106270	K971608	CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM	DYB	1997-07-21
16	1919944744	K971572	VISTA BRITE TIP CATHETERS	DQY	1997-07-14
16	1937191959	K971010	PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETERS	LIT	1997-06-18
16	1753422548	K970854	5 FR AND 6 FR INFINITI ANGIOGRAPHIC CATHETER	DQO	1997-09-30
16	1065981560	K970392	CORDIS AVANTI+CATHETER SHEATH INTRODUCER SYSTEM	DRE	1997-04-24
16	2037428869	K965247	ENVOY GUIDING CATHETER	DQY	1997-07-23
16	1068480928	K965211	VISTA BRITE TIP CATHETERS	DQY	1997-03-11
16	1351741230	K963962	VISTA BRITE TIP CATHETERS	DQY	1997-05-07
16	1018556092	K963000	MAXI LD PTA BALLOON CATHETER	LIT	1997-02-20
16	1474014087	K962830	VISTA BRITE TIP CATHETERS	DQY	1996-10-17
16	1890153802	K962759	4F NYLEX ANGIOGRAPHIC CATHETER	DQO	1996-10-10
16	1909928345	K962746	CORDIS AVANTI TRANS-RADIAL CATHETER SHEATH INTRODUCER KIT	DYB	1996-10-11
16	1358273263	K962362	CORDIS ENVOY & VISTA BRITE TIP GUIDING CATHETERS	DQY	1996-08-08
16	1132003613	K960975	1-4F INFINITI ANGIOGRAPHIC CATHETER	DQO	1996-04-02
16	1968663730	K955728	CORDIS BILIARY STENT	FGE	1996-05-08
16	1450466118	K952185	CORDIS BRITE TIP, ENVOY GUIDING CATHETER	DQY	1995-08-02
16	1045472743	K945616	CORDIS AVANTI CATHETER SHEATH INTRODUCER	DYB	1995-03-29
16	1523990084	K945524	CORDIS INTRODUCING CATHETER	DYB	1995-04-26
16	1644348551	K942094	CORDIS SAVVY PTA BALLOON CATHETER	LIT	1994-11-01
16	1594675084	K932733	CORDIS CATHETER SHEATH INTRODUCER	DYB	1993-08-26
16	1424051656	K930479	NYLEX CATHETERS	DQO	1993-04-21
16	1416891307	K915836	CORDIS 5.0 FRENCH SUPER TORQUE CATHETERS	DQO	1992-02-11
16	1090910600	K914352	CORDIS OBTURATOR	DYB	1991-11-22
16	1875904449	K914007	CORDIS 5.2 FRENCH SUPER TORQUE PLUS CARDIO CATH	DQO	1991-10-18
16	1285030563	K913801	CORDIS CATH SHEATH INTRO SYST PLUS W/UNISTASIS VAL	DYB	1991-10-16
16	1644296894	K911794	CATH SHEATH INTRODUCER SYST PLUS W/UNISTASIS VALVE	DYB	1991-07-19
16	1582238836	K862975	MODIFIED PTCA GUIDING CATHETERS	DQY	1986-09-23
16	1807231463	K862006	STAND & HIGH FLOW FEMORAL-VENTRICULAR PIGTAIL CATH	DQO	1986-06-27
16	1519318316	K861082	CORDIS CATH SHEATH INTRODUC/MID-LENGTH SHEATH SYST	DYB	1986-05-05
16	1545650158	K854576	MODIFIED CORDIS PTCA GUIDING CATHETERS	DQO	1986-02-26
16	1659106600	K851947	PTCA GUIDING CATHETER	DYB	1985-08-16
16	1997862402	K844161	PTCA GUIDING CATHER	DQO	1985-01-02
16	1321844067	K812231	INTRAVENOUS ADMINISTRATION SET	FPA	1981-08-20
16	1477130011	K232573	INFINITI™ Ambi Angiographic Catheter	DQO	2023-11-21
16	1258595950	K212977	SUPER TORQUE MB Angiographic Catheter with Radiopaque markerbands	DQO	2022-02-17
16	1199255350	K181836	4F Infiniti Angiographic Catheter, 4F & 5F Nylex Angiography Catheters, 4F & 5F Tempo Angiography Catheters	DQO	2018-08-08
16	1159640164	K143412	ADROIT Guiding Catheter	DQY	2015-01-14
16	1238554626	K133843	SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY DILATATION CATHETER	LIT	2014-06-27
16	1921733537	K131225	ADROIT GUIDING CATHETER	DQY	2013-05-29
16	1996256701	K121442	POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER	LIT	2012-06-14
16	1127514678	K112797	POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER	LIT	2012-05-04
16	1976915075	K083814	OUTBACK LTD RE-ENTRY CATHETER, MODEL: OTB42120	PDU	2009-01-13
16	1088709546	K071189	CORDIS AVIATOR PLUS PTA BALLOON DILATATION CATHETER	LIT	2007-05-16
16	1996665237	K062798	SMART NITINOL SELF-EXPANDING STENT, MODEL C06120MB, C07120MB, C08120MB, C06150MB, C07150MB, C08150MB	FGE	2008-02-06
16	1172496999	K060877	PALMAZ BLUE .014 TRANSHEPATIC BILIARY STENT SYSTEM-MODEL PB1550,BAS,BAX,PB1560,BAS,BAX,PB1850,BAS,BAXPB1860BAS,BAX	FGE	2006-04-27
16	1930901320	K042969	MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM	FGE	2004-11-08
16	1924043141	K041796	PRECISE RX NITINOL STENT TRANSHEPATIC BILIARY SYSTEM	FGE	2004-08-03
16	2024525823	K040413	CORDIS PALMAZ BLUE TRANSHEPATIC BILIARY STENT ON SLALOM .018 DELIVERY SYSTEM	FGE	2004-06-21
16	1327178070	K034050	CORDIS OPTEASE VENA CAVA FILTER, MODELS 466-F220A AND 466-F220B; RETRIEVABLE CATHETER, MODEL 466-C220F	DTK	2004-03-22
16	1050015389	K033535	LUMEND FRONTRUNNER CTO CATHETER AND ACCESSORIES	PDU	2004-01-07
16	1093058483	K033394	CORDIS PALMAZ GENESIS TRANSHEPATIC BILLARY STENT ON OPTA PRO .035 DELIVERY SYSTEM	FGE	2003-12-22
16	1821114513	K032737	CORDIS POWERFLEX EXTREME PTA BALLOON CATHETER, CORDIS POWERFLEX PLUS PTA BALLOON CATHETER, CORDIS POWERFLEX P3 PTA	DQY	2003-10-02
16	1379515430	K032457	MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM	FGE	2003-09-04
16	1544628937	K032137	PRECISE RX NITINOL STENT TRANSHEPATIC BILIARY SYSTEM	FGE	2003-09-17
16	1323986731	K031777	MODEIFICATION TO: SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM	FGE	2003-07-07
16	1763898054	K031197	MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM	FGE	2003-06-16
16	2060715334	K030409	SMART NITINOL STENT ENDOSCOPIC BILIARY SYSTEM	FGE	2003-03-10
16	1881403797	K023907	CORDIS MAXI LD LARGE DIAMETER BALLOON DILATATION CATHETER, CORDIS MAXI LD PTA BALLOON DILATION CATHETER	KNQ	2002-12-18
16	1399288344	K023217	MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM	FGE	2002-10-25
16	1675609728	K021898	SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM	FGE	2002-08-14
16	1495380792	K021593	MODIFICATION TO ENVOY AND VISTA BRITE TIP	DQY	2002-06-13
16	1539481916	K021345	MODIFICATION TO CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON SLALOM .018 DELIVERY SYSTEM	FGE	2002-06-28
16	1502781189	K020052	SMART NITINOL STENT TRANSHEPATIC BILIARY SYSTEM	FGE	2002-02-11
16	1920427520	K012993	MODIFICATION TO PRECISE NITINOL STENT TRANSHEPATIC BILIARY SYSTEM	FGE	2001-10-05
16	1769842285	K012590	CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON OPTA PRO .035 DELIVERY SYSTEM	FGE	2001-09-07
16	1020161607	K012056	CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON SLALOM .018 DELIVERY SYSTEM	FGE	2001-08-01
16	2063465766	K010445	PRECISE NITINOL STENT TRANSHEPATIC BILLARY SYSTEM	FGE	2001-03-16
16	1211805660	K003964	TRAPEASE PERMANENT VENA FILTER AND INTRODUCTION KIT, MODELS 466-P306A AND 466-P306B	DTK	2001-01-19
16	1784852313	K003365	S.M.A.R.T NITINOL STENT ENDOSOPIC BILLARY SYSTEM (VARIOUS)	FGE	2000-11-22
16	1700911067	K003336	MODIFICATION TO S.M.A.R.T NITINOL STENT TRANSHEPATIC BILIARY SYSTEM	FGE	2000-11-22
16	1969838353	K003159	CORDIS SLALOM PTA BALLOON CATHETER	LIT	2000-10-30
16	1962391027	K001843	S.M.A.R.T. NITINOL STENT TRANSHEPATIC BILIARY SYSTEM	FGE	2000-07-18
16	1896786840	K001258	BX TRANSHEPATIC BILIARY STENT AND DELIVERY SYSTEM	FGE	2000-06-27
16	1912833564	K001135	6F & 7F INTRODUCING CATHETERS (MODIFICATION)	DYB	2000-07-03
16	1468669424	K000715	ENVOY AND VISTA BRITE TIP	DQY	2000-03-31
16	2022391269	K000579	TEMPO AQUA ANGIOGRAPHIC CATHETER	DQO	2000-05-03
16	1212068735	K000564	CORDIS MEDIUM PALMAZ TRANSHEPATIC BILIARY STENT & DELIVERY	FGE	2000-03-23
16	2006219809	K000062	CORDIS TRAPEASE PERMANENT VENA CAVA FILTER AND INTRODUCTION KIT	DTK	2000-07-07
16	1344358468
16	1365229487
16	1600648372
16	1702296075
16	1805410413
16	1966966356
16	1037529483
16	1050015389
16	1103542434
16	1126855337
16	1168674909
16	1204978297
16	1286294004
16	1288184286
16	1387963507
16	1522527140
16	1625197804
16	1651424905
16	1671512063

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
FGE	28	2008-02-06
DQO	17	2023-11-21
DQY	17	2015-01-14
DYB	14	2000-07-03
LIT	11	2014-06-27
DTK	3	2004-03-22
PDU	2	2009-01-13
KNQ	2	2002-12-18
MIH	1	2018-11-27
NIP	1	2012-11-07
NIM	1	2006-09-22
NIO	1	2003-08-12
DRE	1	1997-04-24
FPA	1	1981-08-20