# K111972: Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm Cardioplegia Deliv.,Affinity Hollow Fiber Oxygenator,Aaf

- Pathway: 510(k) (Special)
- Applicant: Medtronic, Inc.
- Decided: Jul 27, 2011 after 16 days
- Product code: KFM (Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type)
- Device class: 2
- Regulation: 21 CFR 870.4360
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K840002 (1984). 74 ancestors in all.
5 later devices descend from it; 1 cites it directly.
1 of 80 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K852807: Bio Medicus Bio Pump Model BP-50, Bio Medicus, Inc. (1985) Summary page 5.
- K973011: BPX80 Bio-Pump (BPX80), Medtronic Bio-Medicus, Inc. (1998) Summary page 5.
- K050109: Trillium Biopump Plus, Model BPX80T, Medtronic Perfusion Systems (2005) Summary page 5.
- K111658: Affinity CP Centrifugal Bllod Pump with Carmeda Bioactive Surface, Medtronic, Inc. (2011) Summary page 5.
- K003724: Cbmyotherm XP Cardioplegia Delivery System with Carmeda Bioactive Surface, Models CB41 and CB41-B, Medtronic Vascular (2000) Summary page 5.
- K011864: Trillium Myotherm XP Cardioplegia Delivery System, Models 41, 41-B, Medtronic Vascular (2001)
- K000379: Modofication to Afffinity 38 Micro Arterial Blood Filter with Carmeda Bioactive Surface, Models CB351/CB352, Medtronic Vascular (2000) Summary page 5.
- K013084: Affinity 38 Micon Arterial Filter with Trillium Biopassive Surface, Model 351T, Medtronic Perfusion Systems (2001) Summary page 5.
- K033468: Affinity 20U Arterial Filter with Trillium Biosurface, Medtronic Perfusion Systems (2003) Summary page 5.
- K071253: Affinity Pediatric Arterial Filter, Model S4014 and with Carmeda Bioactive Surface, Model CB4014, Medtronic Vascular (2007) Summary page 5.
- K933586: Minimax Plus Hollow Fiber Oxygenator (with or Without Medtronic/Carmeda Bioactive Surface, Medtronic Vascular (1994) Summary page 5.
- K973760: Affinity Hollow Fiber Oxygenator with Trillium Biopassive Surface, Avecor Cardiovascular, Inc. (1998) Summary page 5.
- K000430: Affinity NT Hollow Fiber Oxygenator with Plasma Resistant Fiber with Carmeda Bioactive Surface, Model CB511, Medtronic Vascular (2000) Summary page 5.
- K926226: Intersept Filtered Cardiotomy Reservoir, Medtronic Vascular (1993) Summary page 5.
- K936003: Affinity CVR, Avecor Cardiovascular, Inc. (1994) Summary page 5.
- K021287: Trillium Affinity NT Cardiotomy Venous Reservoir, Models 540T, 541TT, Medtronic Perfusion Systems (2002) Summary page 5.
- K920774: MVR Collapsible Venous Reservoir Bag, Medtronic Vascular (1992) Summary page 5.
- K830858: Bio-Probe System-Blood Flow Probe, Bio Medicus, Inc. (1983) Summary page 5.
- K012747: Trillium Bio Disposable Blood Flow Probe (Models DP38T & FP38P), Medtronic Perfusion Systems (2001) Summary page 5.
- K910421: Saturation/Hematocrit Monitor System, Medtronic Vascular (1991) Summary page 5.
- K012743: Trillium Tri-Optic Measurement Cell, Model TMC 25T, TMC38 T, TMC 50T, Medtronic Perfusion Systems (2001) Summary page 5.
- K891687: Extracorporeal Circuit with Bio-Active Surface, Medtronic Blood Systems, Inc. (1989) Summary page 5.
- K902845: Gentle Header, Enhanced Perfusion Systems, Inc. (1990) Summary page 5.
- K012538: Tubing and Connectors with Trillium Biopassive Surface, Medtronic Vascular (2001) Summary page 5.
- K031700: Medtronic Resting Heart System, Model AAR1000 and 711, Medtronic Perfusion Systems (2003) Summary page 5.
- K790563: Adapters-Y-Type, Dlp, Inc. (1979) Summary page 5.
- K790564: Adapter-Straight, Dlp, Inc. (1979) Summary page 5.
- K791498: Adapter-Y Type/Coronary Perfusion, Dlp, Inc. (1979) Summary page 5.
- K841482: Pressure Catheter Placement Set 50010, Dlp, Inc. (1984) Summary page 5.
- K850385: Intracardiac Sump 12010, Dlp, Inc. (1985) Summary page 5.
- K790565: Aortic Root Cannula, Dlp, Inc. (1979) Summary page 5.
- K810548: Cardiopulminary Bypass Catheter Cannula, Dlp, Inc. (1981) Summary page 5.
- K834039: Infant Vent Catheter 12001 W/Side Vent, Dlp, Inc. (1984) Summary page 5.
- K865079: Aspirating Needle, Catalog Code #12006, Dlp, Inc. (1987) Summary page 5.
- K840001: Arterial Cannula Straight Beveled Tip, Dlp, Inc. (1984) Summary page 5.
- K840002: Arterial Cannula Curved Beveled Tip, Dlp, Inc. (1984) Summary page 5.
- K031037: Eopa Elongated One-Piece Arterial Cannula and Guidewire, Medtronic Perfusion Systems (2003) Summary page 5.
- K031518: Eopa Cap Elongated One-Piece Arterial Cannula with Pressure Monitoring Line, Models 774XX, 775XX, 776XX, 777XX, 788XX,, Medtronic Vascular (2003) Summary page 5.
- K033416: Select 3D Arterial Cannula with Carmeda Bioactive Surface and Select Cap Arterial Cannula with Carmeda Bioactive Surface, Medtronic Perfusion Systems (2003) Summary page 5.
- K043179: Select 3D Arterial Cannula, Medtronic Perfusion Systems (2005) Summary page 5.
- K061254: Eopa 3D Arterial Cannula, Models 78220,78222,78320,783222, Medtronic Perfusion Systems (2006)
- K841275: Fine Needle Aspiration Device, Gyneco, Inc. (1984) Summary page 6.
- K845045: Venous Return  Catheter SS-1, Dlp, Inc. (1985) Summary page 6.
- K031776: MC2X Multi-Stage Venous Cannula, Medtronic Perfusion Systems (2003)
- K031827: Ultraflex Venous Cannula, Model 970XX and CB970XX, Medtronic Perfusion Systems (2003) Summary page 6.
- K033264: Malleable Single Stage Venous Cannula with Carmeda Bioactive Surface, Model CB681XX Series, Medtronic Perfusion Systems (2003) Summary page 6.
- K052372: MC2X Multi-Stage Venous Cannula, Models 91437, 91437C, Medtronic Perfusion Systems (2005) Summary page 6.
- K872033: Bio-Medicus Cannula-Tubing, Bio Medicus, Inc. (1987) Summary page 6.
- K875353: Percutaneous Arterial/Venous Cannula Placement Kit, Dlp, Inc. (1988) Summary page 6.
- K884129: Bio-Medicus Percutaneous Cannula & Introducer Set, Bio Medicus, Inc. (1988) Summary page 6.
- K915268: Catheter Two Stage Venous Return, Dlp, Inc. (1992) Summary page 6.
- K924642: Medtronic Bio-Medicus Femoral Cannula/Introducer, Medtronic Bio-Medicus, Inc. (1993) Summary page 6.
- K052524: Bio-Medicus Multi-Stage Venous Femoral Percutaneous Kit, Medtronic Perfusion Systems (2005) Summary page 6.

## Most influential descendants
- K120988: DLP Single Stage Venous Cannula, DLP Right Angle Single Stage Venous Cannula, DLP Single Stage Venous Cannula with Right (2012), 4 descendants of its own
- K140165: MC2 Two-Stage Venous Cannula, Oval MC2 Two-Stage Venous Cannula, Thin Wall Two-Stage Venous Cannula, MC2X Three-Stage VE (2014), 2 descendants of its own
- K251258: MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous Cannula (2025), 1 descendant of its own
- K262052: Tri Stage Venous Cannulae (2026), 0 descendants of its own
- K250937: Venous Return Cannulae (2026), 0 descendants of its own

## Indications for use
The Affinity CP Centrifugal Blood Pump with Carmeda BioActive Surface is used to pump blood through the extracorporeal bypass circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to 6 hours). It is also indicated for use in extracorporeal support systems (for periods up to 6 hours) not requiring complete cardiopulmonary bypass (eg, valvuloplasty, circulatory support during mitral valve reoperation, surgery of the vena Cava or aorta, liver transplants). The MYOtherm XP® is a device intended for the mixing, warming/cooling and delivery of oxygenated blood/cardioplegia solution in a predetermined ratio. The Affinity Arterial Filter is indicated for use in cardiopulmonary bypass procedures up to 6 hours in duration for the removal of particulate and gaseous microemboli. The Affinity NT Hollow Fiber Oxygenator wit Plasma Resistant Fiber is intended to be used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass procedures up to 6 hours in duration. The AFFINITY® NT Integrated CVR Membrane Oxygenator (Plasma Resistant Fiber [PRF] Oxygenator) is intended to be used in an extracorporeal perfusion circuit to collect venous and cardiotomy suctioned blood, cool or warm the blood and oxygenate and remove carbon dioxide from the blood during routine cardiopulmonary bypass procedures up to 6 hours in duration. This product, is indicated for use during cardiopulmonary bypass surgery in an extracorporeal circuit utilizing a membrane oxygenator. The MVR® Holder (Model MVR-SH) is indicated for use with the MVR® Collapsible Venous Reservoir Bag. This product is indicated for use in the extracorporeal circuit during cardiopulmonary bypass surgery. This product is indicated for use in the extracorporeal circuit during cardiopulmonary bypass surgery. This product is indicated for use in the extracorporeal circuit during cardiopulmonary bypass surgery. The Medtronic® Resting Heard"' Module is indicated for use in surgical procedures requiring extracorporeal circulatory support, gas exchange, and thermal regulation. The device is indicated for use in procedures requiring blood flow rate of 1-6 1pm and lasting up to six hours. The system is indicated for use only with the Bio-Console®. The VARD is indicated for use only with the AAR1000. The Bio-Pumnp+®)Blood Pump in the Medtronic® Resting HeartTm Module is indicated, for use only with the Bio-Console®. The Carmeda® AFFINITY® NT Oxygenator and Carmeda®D AFFINITY® Arterial Filter in the Medtronic® Resting HeartTm Module have the same indications for use as a Carmeda® AFFINITY® NT Oxygenator and Carmeda® AFFINITY® Arterial Filter used in other extracorporeal circuits. This adapter is intended for use in conjunction with the delivery of cardioplegia solution. This cannula is intended for use in conjunction with cardiopulmonary bypass surgery for delivering cardioplegia solution. The cannula may also be used to aspirate air from the aorta at the conclusion of the bypass procedure. The #23009 cannula may also be used to monitor pressure in the aorta. These cannulae are intended for use in perfusion of the ascending aorta during short term (6 hours or less) cardiopulmonary bypass. These cannulae are intended for collection of venous blood from the right side of the heart via the superior and inferior vena cava. during cardiopulmonary bypass surgery up to six hours or less. This cannula is intended for rapid femoral venous and arterial access for short term cardiopulmonary bypass.

Source page: https://510kreport.com/device/K111972
Methodology: https://510kreport.com/methodology