510(k) K030231 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
CORONARY ARTERY PERFUSION CANNULA WITH SELF-INFLATING BALLOON
| Applicant | Sorin Group Italia S.R.L., Mirandola, IT |
| Decision | Substantially Equivalent, Apr 18, 2003 |
| Received | Jan 22, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K030231
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 8, 2016 | Sorin Group USA, Inc. Coronary Artery Perfusion Cannula with Balloon (part number CP-2200X). The Coronary Artery Perfusion Cannula with Balloon The Cannula consists of a single lumen vinyl tube provided for with a vinyl fe Terminated |
DWF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.