510(k) K100274 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
MIAR (MINIMALLY INVASIVE AORTIC ROOT) CANNULA WITH FLOW-GUARD, MODELS 11012L AND 11014L
| Applicant | Medtronic, Inc., Minneapolis MN, US |
| Decision | Substantially Equivalent, May 10, 2010 |
| Received | Jan 29, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100274
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 13, 2025 | Medtronic Perfusion Systems Aortic Root Cannula:
1. DLP Aortic Root Cannula
A. CANNULA 11012 AR FLOWGUARD 12GA, model no
11012
B. CANNULA 11014 AR FLOWGUARD 14GA, model no.
11014
2. MiAR Cannula:
A. CANNULA 11012L AR FLOWGUARD Open, Classified |
DWF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.