510(k) K953945 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH ELONGATED & TREADED CUFF & INTRODUCER STYLET
| Applicant | Dlp, Inc., Grand Rapids MI, US |
| Decision | Substantially Equivalent, Mar 26, 1996 |
| Received | Aug 21, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K953945
| 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 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.