510(k) K120612 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
MEDTRONIC CLEAR INTRAVACULAR ARTERIOTOMY SHUNT
| Applicant | Medtronic, Inc., Minneapolis MN, US |
| Decision | Substantially Equivalent, May 25, 2012 |
| Received | Feb 29, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K120612
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 10, 2024 | Medtronic Perfusion Systems Medtronic Intracoronary Shunts:
a) ClearView 1.00 mm Intracoronary Shunt, Model Numbers: 31100;
b) ClearView 1.25 mm Intracoronary Shunt, Model Numbers: 31125;
c) ClearView 2.00 mm Intracoronary Open, Classified |
DWF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.