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510(k) K860149 · DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

VENOUS PERFUSION CANNULA W/CUFF CAT. NO. 94015

Applicant	Dlp, Inc., Grand Rapids MI, US
Decision	Substantially Equivalent, Mar 31, 1986
Received	Jan 15, 1986
Type	Traditional
FDA record	Open on fda.gov

Recalls that name K860149

Date	Firm and product	Code	Linked 510(k)
May 20, 2026	Medtronic Perfusion Systems Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94113T; Cardiopulmonary bypass vascular catheter Open, Classified	DWF	None listed
May 20, 2026	Medtronic Perfusion Systems Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94115T; Cardiopulmonary bypass vascular catheter Open, Classified	DWF	None listed
May 20, 2026	Medtronic Perfusion Systems Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94215T; Cardiopulmonary bypass vascular catheter Open, Classified	DWF	None listed
May 20, 2026	Medtronic Perfusion Systems Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94665; Cardiopulmonary bypass vascular catheter Open, Classified	DWF	None listed
May 20, 2026	Medtronic Perfusion Systems Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94725; Cardiopulmonary bypass vascular catheter Open, Classified	DWF	None listed
May 20, 2026	Medtronic Perfusion Systems Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913; Cardiopulmonary bypass vascular catheter Open, Classified	DWF	None listed
May 20, 2026	Medtronic Perfusion Systems Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913L; Cardiopulmonary bypass vascular catheter Open, Classified	DWF	None listed
May 20, 2026	Medtronic Perfusion Systems Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94915; Cardiopulmonary bypass vascular catheter Open, Classified	DWF	None listed
May 20, 2026	Medtronic Perfusion Systems Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94965; Cardiopulmonary bypass vascular catheter Open, Classified	DWF	None listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.