510(k) K033416 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
SELECT 3D ARTERIAL CANNULA WITH CARMEDA BIOACTIVE SURFACE AND SELECT CAP ARTERIAL CANNULA WITH CARMEDA BIOACTIVE SURFACE
| Applicant | Medtronic Perfusion Systems, Minneapolis MN, US |
| Decision | Substantially Equivalent, Nov 5, 2003 |
| Received | Oct 27, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K033416
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 20, 2014 | Medtronic Inc. Cardiac Rhythm Disease Management Medtronic Select CAP Arterial Cannulae. Non-Vented, Carmeda Coated, model CB78722 (22 Fr.). Sterilized using Ethylene Oxide. Non-pyrogenic.
The Select 3D Arterial Cannulae has clear flexible, th Terminated |
DWF | None listed |
| Jul 24, 2008 | Medtronic Perfusion Systems Medtronic Select 3D and Select CAP Aterial Cannulae with flexible, thin wall wire-wound PVC bodies with angled, beveled tips. Catalog Number: CB78722 Terminated |
DWF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.