510(k) K043179 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
SELECT 3D ARTERIAL CANNULA
| Applicant | Medtronic Perfusion Systems, Minneapolis MN, US |
| Decision | Substantially Equivalent, Feb 8, 2005 |
| Received | Nov 17, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K043179
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 20, 2014 | Medtronic Inc. Cardiac Rhythm Disease Management Medtronic Select 3D Arterial Cannulae. Vented, models 78618 (18 Fr.) and 78620 (20 Fr.). Non-Vented Cannulae, models 78718 (18 Fr.) and 78720 (20 Fr.). Sterilized using Ethylene Oxide. Non-pyroge Terminated |
DWF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.