FDA applicant
Medtronic Perfusion Systems
FDA records 29 decisions for Medtronic Perfusion Systems (Minneapolis, MN) from 2000 to 2024: 29 510(k) clearances. Most are in product codes DWF (Catheter, Cannula And Tubing, Vascular…) and DTM (Filter, Blood, Cardiopulmonary Bypass…). Its devices cite 57 predicates, 6 of them its own earlier devices. 13 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Medtronic Perfusion Systems’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
4in 2026
Class I Class II/III not classified
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