MEDTRONIC PERFUSION SYSTEMS

Matched from indexed company URL: Medtronic Perfusion Systems

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
1718389	1718389	MEDTRONIC PERFUSION SYSTEMS	1	N	2026-01-01	18501 E Plaza Dr PARKER CO US 80134
2184009	1000116158	MEDTRONIC PERFUSION SYSTEMS	1	N	2026-01-01	7611 Northland Dr Minneapolis MN US 55428

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
5792	1509855441	P160043	RESOLUTE ONYX ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM	NIQ	2017-04-28
5792	1715533001	P110013	RESOLUTE MICROTRAC/RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM	NIQ	2012-02-17
5792	1598640776	P100040	VALIANT THORACIC STENT GRAFT SYSTEM	MIH	2011-04-01
5792	1783538380	P100021	MEDTRONIC VASCULAR ENDURANT STENT GRAFT SYSTEM	MIH	2010-12-16
5792	1126185707	P030009	DRIVER OVER-THE-WIRE, RAPID EXCHANGE, AND MULTI-EXCHANGE CORONARY STENT SYSTEMS	MAF	2003-10-01
5792	1929023127	K994208	AFFINITY 20 MICRON ARTERIAL BLOOD FILTER, MODEL 353/354	DTM	2000-01-13
5792	1379164924	K994171	MEDTRONIC AORTOCORONARY SHUNT AND SEPARATELY PACKAGED ARTERIOTOMY CANNULAE	DWF	2000-04-27
5792	1837660933	K991066	MADTRONIC DLP ARTERIAL CANNULAE	DWF	1999-09-14
5792	1049149074	K982755	MODIFICATION OF AUTOTRANSFUSION APPARATUS (AUTOLOG)	CAC	1998-08-20
5791	1262207434	K981815	HEPTRAC ELECTRONIC QUALITY CONTROL	JPA	1998-07-30
5792	1262207434	K981815	HEPTRAC ELECTRONIC QUALITY CONTROL	JPA	1998-07-30
5792	1012416779	K973760	AFFINITY HOLLOW FIBER OXYGENATOR WITH TRILLIUM BIOPASSIVE SURFACE	DTZ	1998-02-18
5792	1413668846	K973485	CLEARVIEW BLOWER/MISTER	FQH	1997-12-08
5792	1233260970	K973237	CSS-CARDIOPLEGIA SAFETY SYSTEM	DWB	1998-04-27
5792	1576003066	K973011	BPX80 BIO-PUMP (BPX80)	KFM	1998-02-25
5792	1358774335	K972894	AUTOTRANSFUSION APPARTUS (AUTOLOG)	CAC	1998-04-27
5792	1839638185	K971105	MYOTHERM (TM) XP CARDIOPLEGIA DELIVERY SYSTEM	DTN	1997-07-11
5792	1285562439	K954501	BIOTREND OXYGEN SATURATION & HEMATOCRIT SYSTEM	DTY	1996-01-16
5791	1029069090	K954202	PLATELET FUNCTION TEST ASSAY CARTRIDGES FOR THE HEPCON HMS	JPA	1996-06-20
5792	1029069090	K954202	PLATELET FUNCTION TEST ASSAY CARTRIDGES FOR THE HEPCON HMS	JPA	1996-06-20
5792	1006829122	K953945	RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH ELONGATED & TREADED CUFF & INTRODUCER STYLET	DWF	1996-03-26
5791	1586688210	K953870	ACTTRAC ELECTRONIC CONTROL DEVICE FOR THE ACT & ACT II COAGULATION INSTRUMENTS	GKN	1995-10-31
5792	1586688210	K953870	ACTTRAC ELECTRONIC CONTROL DEVICE FOR THE ACT & ACT II COAGULATION INSTRUMENTS	GKN	1995-10-31
5792	2040082943	K953564	MEDTRONIC OVERPRESSURE/VACUUM RELIEF VALVE	DTL	1996-02-02
5792	1184789281	K953118	CARACELL	CAC	1996-02-23
5792	1579200306	K952532	AFFINITY ARTERIAL BLOOD FILTER	DTM	1995-10-06
5792	1089730973	K950754	MACRO SUCTION TUBE MODEL NO 10061	GCY	1995-04-25
5791	1442875916	K944115	HEPARIN ASSAY CARTRIDGES AND CONTROLS	GFT	1995-03-24
5792	1442875916	K944115	HEPARIN ASSAY CARTRIDGES AND CONTROLS	GFT	1995-03-24
5792	1277809788	K941921	BIO-MEDICUS BIO-CONSOLE MODELS 540, 540A,B,C,D,E, & 550	DWA	1994-07-20
5791	1657613488	K940426	MEDTRONIC HEMOTEC ACT II AUTOMATED COAGULATION TIMER	GKN	1994-09-20
5792	1657613488	K940426	MEDTRONIC HEMOTEC ACT II AUTOMATED COAGULATION TIMER	GKN	1994-09-20
5792	1657835390	K936091	MEDTRONIC BIO-MEDICUS BIO-CONSOLE MODEL 550M PUMP SPEED CONTROLLER	DWA	1994-12-23
5792	1069033071	K936003	AFFINITY CVR	DTN	1994-06-20
5792	1746808590	K935717	AFFINITY VENOUS RESERVIOR BAG	DTN	1994-05-10
5792	2029986886	K933586	MINIMAX PLUS HOLLOW FIBER OXYGENATOR (WITH OR WITHOUT MEDTRONIC/CARMEDA BIOACTIVE SURFACE	DTZ	1994-02-07
5792	1848590009	K932252	AFFINITY HOLLOW FIBER OXYGENATOR	DTZ	1993-11-19
5792	1792421614	K930154	EL2-SERIES BLOOD COLLECTION REERVOIR	DTN	1993-07-01
5792	1566208000	K926357	MEDTRONIC BIO-MEDICUS HANDCRANK MODEL 150	DWA	1993-06-02
5792	1233480495	K926250	ELECTROMEDICS EL-SERIES CARDIOTOMY RESERVOIR	DTN	1993-02-19
5792	2063724837	K926226	INTERSEPT FILTERED CARDIOTOMY RESERVOIR	DTZ	1993-06-22
5792	1298635699	K924643	MEDTRONIC BIO-MEDICUS CANNULA INSERTION KIT	DWF	1992-12-08
5792	1577251745	K924642	MEDTRONIC BIO-MEDICUS FEMORAL CANNULA/INTRODUCER	DWF	1993-03-26
5792	1780692306	K924529	SIGNATURE(TM) CUSTOM TUBING PACK	DWF	1993-06-23
5792	1372039785	K924208	BIO-PROBE(R) BLOOD FLOW MONITORING SYST(TX-50/50P)	DPT	1993-07-08
5791	1042622343	K923594	CLOTTRAC COAGULATION CONTROL	JBP	1992-09-21
5792	1042622343	K923594	CLOTTRAC COAGULATION CONTROL	JBP	1992-09-21
5791	1592730763	K922031	HMS PURPLE AND BLACK HEPARIN CARTRIDGES & CONTROL	JOX	1992-07-21
5792	1592730763	K922031	HMS PURPLE AND BLACK HEPARIN CARTRIDGES & CONTROL	JOX	1992-07-21
5792	1355832014	K920774	MVR COLLAPSIBLE VENOUS RESERVOIR BAG	DTN	1992-10-19
5792	2017364315	K915268	CATHETER TWO STAGE VENOUS RETURN	DWF	1992-07-27
5792	1579642789	K912229	IMA ELECTROCAUTERY ELECTRODE CAT. #60002/60003	GEI	1991-09-25
5792	1964649870	K911790	MINIMAX (TM) COLLAPSIBLE VENOUS RESERVOIR BAG	DTN	1991-08-12
5792	1265657613	K911789	MINIMAX (TM) HARDSHELL VENOUS RES W/INTE CARD FILT	DTP	1991-08-20
5792	1557912609	K911240	HEPCON HMS WITH BODY SURFACE AREA CALCULATION	JOX	1991-07-17
5792	1817082413	K910421	SATURATION/HEMATOCRIT MONITOR SYSTEM	DRY	1991-10-15
5792	1767293924	K903632	INTERSEPT 1375 VENOUS RESERVOIR	DTN	1990-12-17
5791	1810827929	K902081	CLOTTRAC(TM) IBEX HEPARINASE HR ACT CART./CONTROL	JBP	1990-07-03
5792	1810827929	K902081	CLOTTRAC(TM) IBEX HEPARINASE HR ACT CART./CONTROL	JBP	1990-07-03
5792	1000114492	K901815	MODIFIED STERILIZATION OF INTRA-ART(TM) CORONARY	DRE	1990-07-03
5792	1903453004	K901253	(PBS) PORTABLE BYPASS SYSTEM, MODEL 1000	DTZ	1990-09-05
5792	1366715303	K901074	CODE #94315 RETROGRADE CORONARY SINUS PERF CANNULA	DWF	1990-07-06
5792	1371093996	K900994	ANTEGRADE/RETROGRADE Y W/INTEGRAL SELECTOR SWIT.	DTL	1990-08-15
5792	1773575877	K894980	BIO-CAL 370 HEATER/COOLER	DWJ	1989-11-02
5791	1449683244	K894359	CLOTRAC CITRATED WHOLE BLOOD COAGULATION CONTROLS	JPA	1989-09-05
5792	1449683244	K894359	CLOTRAC CITRATED WHOLE BLOOD COAGULATION CONTROLS	JPA	1989-09-05
5791	1713404994	K894317	HEMOTEC HEPCON HMS COAGULATION SYSTEM & ACCESS.	JOX	1989-09-05
5792	1713404994	K894317	HEMOTEC HEPCON HMS COAGULATION SYSTEM & ACCESS.	JOX	1989-09-05
5792	1792400220	K891687	EXTRACORPOREAL CIRCUIT WITH BIO-ACTIVE SURFACE	DTZ	1989-05-31
5792	1070939868	K890707	PHRENIC NERVE PAD & NERVE PAD W/1/4 PERCARDIAL	DWS	1989-04-10
5792	1947513070	K884560	SCIMED ECMOTHERM(TM) HEAT EXCHANGER	DTR	1989-04-03
5792	1825612749	K884129	BIO-MEDICUS PERCUTANEOUS CANNULA & INTRODUCER SET	DQY	1988-12-21
5792	1769442219	K883956	BIO-MEDICUS TUBING CONNECTORS	DTL	1988-10-28
5792	1870401575	K883086	INTERSEPT*PREBYPASS FILTER	KRJ	1988-09-16
5792	1466988851	K882720	SCIMED R30 SILICONE ASSIST RESERVOIR	DTN	1988-09-16
5792	2061634867	K882381	PTI HEART-LIFT(TM) CARDIAC RETRACTION GLOVES-STERI	KGO	1988-07-07
5792	1346743596	K882136	INTERSEPT* OXYGEN GAS LINE FILTER	KRD	1988-08-11
5792	1840862582	K880860	CORONARY OSTIUM OCCLUDER, CATALOG CODE 32015	DQT	1988-05-26
5792	1575377551	K880671	MODIFIED INTERSEPT PEDIATRIC BLOOD FILTER	DTM	1988-05-06
5791	1557859693	K880302	CALCIUM CHLORIDE SOLUTION 0.1M, IN HEPES BUFFER	GGN	1988-02-19
5792	1557859693	K880302	CALCIUM CHLORIDE SOLUTION 0.1M, IN HEPES BUFFER	GGN	1988-02-19
5792	1933898522	K875353	PERCUTANEOUS ARTERIAL/VENOUS CANNULA PLACEMENT KIT	DWF	1988-03-22
5792	1197277755	K873561	ELECTROMEDICS D1079E	DTR	1987-11-05
5792	1254037332	K873423	MAXIMA* COLLAPSIBLE VENOUS RESERVOIR BAG & HOLDER	DTN	1987-11-06
5792	1149064101	K872033	BIO-MEDICUS CANNULA-TUBING	DWF	1987-12-07
5792	1148978549	K865079	ASPIRATING NEEDLE, CATALOG CODE #12006	DWF	1987-03-03
5792	1019887619	K863476	SCIMED MEMBRANE OXYGENATOR SYSTEM - ECMO	DTZ	1986-11-25
5792	1790067583	K860306	BT-795/P AUTOMATED AUTOTRANS	CAC	1986-03-06
5792	1946844382	K860149	VENOUS PERFUSION CANNULA W/CUFF CAT. NO. 94015	DWF	1986-03-31
5791	1423144438	K860122	HEMOTEC ACT HIGH RANGE ACTIVATED CLOTTING TIME	JBP	1986-04-04
5792	1423144438	K860122	HEMOTEC ACT HIGH RANGE ACTIVATED CLOTTING TIME	JBP	1986-04-04
5792	1844773532	K855144	TOURIQUET KIT WITH SNARE	GDJ	1986-02-05
5792	1709422085	K854487	VENOUS RETURN CANNULA W/CUFF 91039	DWF	1986-02-10
5792	1447227286	K853586	PRESSURE SENSING SYRINGE 65000	DTL	1985-11-14
5791	1504690547	K853198	ADDITIONAL HEMOTEC ACT COAGULATION CARTRIDGES	JPA	1985-10-04
5792	1504690547	K853198	ADDITIONAL HEMOTEC ACT COAGULATION CARTRIDGES	JPA	1985-10-04
5792	1703384269	K852807	BIO MEDICUS BIO PUMP MODEL BP-50	KFM	1985-09-30
5792	1850898112	K852698	BIO MEDICUS BIO PUMP MODEL BP-80	KFM	1985-09-30
5792	1518126688	K852232	PRESSURE DISPLAY BOX #60000/TUBING SET #61000	DXS	1985-08-09
5792	1485396561	K852184	ELECTRO-CAUTERY KNIFE CLEANER 6000 1	HAM	1985-06-04
5792	1658538014	K850385	INTRACARDIAC SUMP 12010	DWF	1985-04-29
5792	1674067141	K845046	PUL,MONARY ARTERY VENT CATHETER	DWF	1985-04-03
5792	1374451394	K845045	VENOUS RETURN CATHETER SS-1	DWF	1985-04-03
5792	1657314483	K844918	OCCLUSION & OCCLUSION-IRRIGATION	DQT	1985-08-05
5791	1747774110	K843459	HEMOTEC ACT I SYSTEM	JBP	1984-12-12
5792	1747774110	K843459	HEMOTEC ACT I SYSTEM	JBP	1984-12-12
5792	1024554522	K842375	VENOUS CANNULA W/BENT, TIP WIRE	DWF	1984-08-10
5792	1279658210	K841482	PRESSURE CATHETER PLACEMENT SET 50010	DWF	1984-06-11
5792	1119923243	K840002	ARTERIAL CANNULA CURVED BEVELED TIP	DWF	1984-02-13
5792	1130204206	K840001	ARTERIAL CANNULA STRAIGHT BEVELED TIP	DWF	1984-02-13
5792	1900770799	K834352	ADULT VENT CATHETER	DRA	1984-01-27
5792	1829274315	K834039	INFANT VENT CATHETER 12001 W/SIDE VENT	DWF	1984-01-03
5792	1992637877	K831591	AORTIC ROOT CANNULA W/INTEGRAL PRESS	DWF	1983-06-30
5792	1362570545	K831528	MODEL TP THERMISTOR PROBE	DRF	1983-06-30
5792	1917682852	K830858	BIO-PROBE SYSTEM-BLOOD FLOW PROBE	DPT	1983-06-08
5792	1867758360	K830735	BT 795/A AUTOTRANS	CAC	1983-05-02
5792	1511428891	K830573	PRE VUE	FOZ	1983-03-29

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
DWF	78	2026-01-20
DTZ	25	2024-07-10
DTN	20	2017-03-17
JOX	13	2011-06-08
DTM	12	2026-01-16
OCL	11	2022-12-22
KFM	10	2019-08-27
JPA	9	1998-07-30
CAC	8	2018-08-22
DTL	8	2012-12-13
JBP	8	1992-09-21
DTR	7	2024-02-23
OTD	7	2018-11-21
DWA	7	2013-07-24
GEI	6	2010-02-26
GGN	6	2004-10-18
DPT	5	2014-05-30
FZP	4	2008-05-07
GKN	4	1995-10-31
DRY	3	2014-10-23
QHW	2	2024-04-19
NIQ	2	2017-04-28
FLL	2	2016-05-20
DXS	2	2011-12-02
MIH	2	2011-04-01
DTP	2	2010-09-03
DTY	2	2010-02-17
DTQ	2	2007-03-21
DQY	2	2005-04-13
DRA	2	2001-10-24
GFT	2	1995-03-24
DRE	2	1990-07-03
DQT	2	1988-05-26
GDJ	2	1986-02-05
DWE	2	1981-01-13
PZX	1	2023-08-30
DTW	1	2015-05-08
GAD	1	2013-10-04
GCJ	1	2006-10-11
LDF	1	2004-09-02