# Medtronic Perfusion Systems

- Location (FDA's records): Minneapolis, MN
- FDA decisions: 29 (2000–2024): 29 510(k) clearances
- Product codes: DWF (12), DTM (4), FMF (2), DWA (2), DTN (2), DTP (1), JOX (1), CAC (1), DPT (1), DRY (1), KFM (1), DTZ (1)
- Predicates its devices cite: 57 (6 its own); citations of its devices by later devices: 41 (6 its own)
- Recalls linked to its devices: 13 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Dlp, Inc.: 10 (https://510kreport.com/company/dlp)
- Avecor Cardiovascular, Inc.: 7 (https://510kreport.com/company/avecor-cardiovascular)
- Medtronic Vascular: 6 (https://510kreport.com/company/medtronic-vascular)
- Medtronic Cardiac Surgical Products: 6 (https://510kreport.com/company/medtronic-cardiac-surgical-products)
- Medtronic Blood Systems, Inc.: 5 (https://510kreport.com/company/medtronic-blood-systems)
- Medtronic Bio-Medicus, Inc.: 4 (https://510kreport.com/company/medtronic-bio-medicus)
- Medtronic, Inc.: 3 (https://510kreport.com/company/medtronic)
- Bio Medicus, Inc.: 2 (https://510kreport.com/company/bio-medicus)

## Firms that cite its devices most
- Medtronic, Inc.: 26 (https://510kreport.com/company/medtronic)
- Terumo Cardiovascular Systems Corp.: 3 (https://510kreport.com/company/terumo-cardiovascular-systems)
- Levitronix, LLC: 1 (https://510kreport.com/company/levitronix)
- Lifebridge Medizintechnik AG: 1 (https://510kreport.com/company/lifebridge-medizintechnik)
- Estech, Inc.: 1 (https://510kreport.com/company/estech)
- Novalung GmbH: 1 (https://510kreport.com/company/novalung)
- Medtronic Vascular: 1 (https://510kreport.com/company/medtronic-vascular)
- Avalon Laboratories, LLC: 1 (https://510kreport.com/company/avalon-laboratories)

## Its most-cited devices
- K033416: Select 3D Arterial Cannula with Carmeda Bioactive Surface and Select Cap Arterial Cannula with Carmeda Bioactive Surface (2003), cited by 4
- K031037: Eopa Elongated One-Piece Arterial Cannula and Guidewire (2003), cited by 3
- K052524: Bio-Medicus Multi-Stage Venous Femoral Percutaneous Kit (2005), cited by 3
- K031700: Medtronic Resting Heart System, Model AAR1000 and 711 (2003), cited by 3
- K043179: Select 3D Arterial Cannula (2005), cited by 3
- K061254: Eopa 3D Arterial Cannula, Models 78220,78222,78320,783222 (2006), cited by 2

## Recent decisions
- K240666: 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) (Jul 10, 2024)
- K181954: autoLog IQ Autotransfusion System (Aug 22, 2018)
- K123351: Affinity AF100 Arterial Filter with Carmeda Bioactive Surface (Mar 19, 2013)
- K101186: Affinity Vard Sub-Assembly for CPS (Carmeda Coated), Purgeline (Uncoated), Holding Bag (Sep 3, 2010)
- K090869: Mircsp (Minimally Invasive Retrograde Coronary Sinus Perfusion) Manual Inflate Cannula, Model 94113TD (Aug 27, 2009)
- K080824: Bio-Console 560 (May 7, 2008)
- K061254: Eopa 3D Arterial Cannula, Models 78220,78222,78320,783222 (Jun 23, 2006)
- K052524: Bio-Medicus Multi-Stage Venous Femoral Percutaneous Kit (Nov 22, 2005)

Source page: https://510kreport.com/company/medtronic-perfusion-systems