Medical Device Manufacturer · US , Minneapolis , MN

Medtronic Perfusion Systems

29 submissions · 29 cleared · Since 2000
29
Total
29
Cleared
0
Denied

Medtronic Perfusion Systems — FDA 510(k) Submissions

Medtronic Perfusion Systems has submitted 29 FDA 510(k) premarket notifications since 2000, of which 29 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass, Filter, Blood, Cardiopulmonary Bypass, Arterial Line, Control, Pump Speed, Cardiopulmonary Bypass, Syringe, Piston, Reservoir, Blood, Cardiopulmonary Bypass . Use the specialty filter in the sidebar to narrow results.

29 devices
1–25 of 29
Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface (BB811); Affinity Fusion Oxygenator with Integrated Arterial Filter and Cardiotomy/Venous Reservoir with Balance Biosurface (BB841); Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface NON STERILE (BB811-NS)
K240666 · DTZ Oxygenator,... · Cardiovascular
Jul 2024 124d
autoLog IQ Autotransfusion System
K181954 · CAC Apparatus, Autotransfusion · Cardiovascular
Aug 2018 30d
AFFINITY AF100 ARTERIAL FILTER WITH CARMEDA BIOACTIVE SURFACE
K123351 · DTM Filter, Blood,... · Cardiovascular
Mar 2013 139d
AFFINITY VARD SUB-ASSEMBLY FOR CPS (CARMEDA COATED), PURGELINE (UNCOATED), HOLDING BAG
K101186 · DTP Defoamer, Cardiopulmonary... · Cardiovascular
Sep 2010 128d
MIRCSP (MINIMALLY INVASIVE RETROGRADE CORONARY SINUS PERFUSION) MANUAL INFLATE CANNULA, MODEL 94113TD
K090869 · DWF Catheter, Cannula And... · Cardiovascular
Aug 2009 149d
BIO-CONSOLE 560
K080824 · DWA Control, Pump Speed,... · Cardiovascular
May 2008 44d
EOPA 3D ARTERIAL CANNULA, MODELS 78220,78222,78320,783222
K061254 · DWF Catheter, Cannula And... · Cardiovascular
Jun 2006 50d
BIO-MEDICUS MULTI-STAGE VENOUS FEMORAL PERCUTANEOUS KIT
K052524 · DWF Catheter, Cannula And... · Cardiovascular
Nov 2005 69d
MC2X MULTI-STAGE VENOUS CANNULA, MODELS 91437, 91437C
K052372 · DWF Catheter, Cannula And... · Cardiovascular
Sep 2005 23d
BIO-CONSOLE, MODEL 560
K051303 · DWA Control, Pump Speed,... · Cardiovascular
Jun 2005 22d
HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR
K051040 · JOX Analyzer, Heparin, Automated · Hematology
May 2005 29d
TRILLIUM BIOPUMP PLUS, MODEL BPX80T
K050109 · KFM Pump, Blood,... · Cardiovascular
Feb 2005 24d
SELECT 3D ARTERIAL CANNULA
K043179 · DWF Catheter, Cannula And... · Cardiovascular
Feb 2005 83d
MAGELLAN RATIO DISPENSER KIT
K041830 · FMF Syringe, Piston · General Hospital
Sep 2004 84d
PEDIATRIC AORTIC ROOT CANNULA
K040173 · DWF Catheter, Cannula And... · Cardiovascular
Mar 2004 53d
AFFINITY 20U ARTERIAL FILTER WITH TRILLIUM BIOSURFACE
K033468 · DTM Filter, Blood,... · Cardiovascular
Nov 2003 11d
SELECT 3D ARTERIAL CANNULA WITH CARMEDA BIOACTIVE SURFACE AND SELECT CAP ARTERIAL CANNULA WITH CARMEDA BIOACTIVE SURFACE
K033416 · DWF Catheter, Cannula And... · Cardiovascular
Nov 2003 9d
MALLEABLE SINGLE STAGE VENOUS CANNULA WITH CARMEDA BIOACTIVE SURFACE, MODEL CB681XX SERIES
K033264 · DWF Catheter, Cannula And... · Cardiovascular
Oct 2003 22d
MEDTRONIC RESTING HEART SYSTEM, MODEL AAR1000 AND 711
K031700 · DTN Reservoir, Blood,... · Cardiovascular
Aug 2003 88d
MC2X MULTI-STAGE VENOUS CANNULA
K031776 · DWF Catheter, Cannula And... · Cardiovascular
Jul 2003 45d
ULTRAFLEX VENOUS CANNULA, MODEL 970XX AND CB970XX
K031827 · DWF Catheter, Cannula And... · Cardiovascular
Jul 2003 19d
EOPA ELONGATED ONE-PIECE ARTERIAL CANNULA AND GUIDEWIRE
K031037 · DWF Catheter, Cannula And... · Cardiovascular
May 2003 42d
RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH NO PRESSURE LINE (15 FRENCH, MANUAL AND AUTO INFLATE)
K030696 · DWF Catheter, Cannula And... · Cardiovascular
Apr 2003 36d
TRILLIUM AFFINITY NT CARDIOTOMY VENOUS RESERVOIR, MODELS 540T, 541TT
K021287 · DTN Reservoir, Blood,... · Cardiovascular
May 2002 14d
MAGELLAN RATIO DISPENSER KIT/MAGELLAN SPRAY TIP/MAGELLAN CANNULA TIP
K020147 · FMF Syringe, Piston · General Hospital
Apr 2002 77d
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