510(k) K972503 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
CARDIOPLEGIA ADAPTERS, VESSEL CANULAE, AND AORTIC ROOT CANNULAE
| Applicant | Sorin Group Italia S.R.L., Mirandola, IT |
| Decision | Substantially Equivalent, Aug 26, 1997 |
| Received | Jul 3, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972503
| 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.