510(k) K850385 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
INTRACARDIAC SUMP 12010
| Applicant | Dlp, Inc., Grand Rapids MI, US |
| Decision | Substantially Equivalent, Apr 29, 1985 |
| Received | Feb 1, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K850385
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 10, 2024 | Medtronic Perfusion Systems Medtronic Left Heart Vent Catheters:
a) DLP Intracardiac Sump 20 Fr, Model Number 12012,
b) DLP Left Heart Vent Catheter 10 Fr., Model Number 12008,
c) DLP Left Heart Vent Catheter 13 Fr., Model N Open, Classified |
DWF | None listed |
| Jan 26, 2009 | Medtronic Cardiovascular Revascularization & Surgical Therap DLP(R) Pericardial/Intracardiac Sump Cannulae, 20 Fr., P/N: 12112. This product is intended for draining the pericardial sac or the cardiac chambers. Terminated |
DWF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.