510(k) K010974 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
RETROGRADE CARDIOPLEGIA CANNULA, MANUAL-INFLATING, WITH MALLEABLE OR GUIDWIRE STYLET
| Applicant | Sorin Group Italia S.R.L., Mirandola, IT |
| Decision | Substantially Equivalent, Jun 18, 2001 |
| Received | Apr 2, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010974
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.