510(k) K900753 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
SHILEY VEIN IRRIGATION CANNULA (BEVELED & BLUNT)
| Applicant | Shiley, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Apr 10, 1990 |
| Received | Feb 16, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K900753
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 24, 2020 | LivaNova USA Inc. Vein Irrigation Cannula with blunt tip. ASY BIC, STERILE 25/CS REF/ GTIN for Insert Label:BIC/ 00803622133091 Terminated |
DWF | None listed |
| Apr 24, 2020 | LivaNova USA Inc. Vein Irrigation Cannula with blunt tip. ASY VIC, STERILE 25/CS REF/ GTIN for Insert Label: VIC/ 00803622133107 Terminated |
DWF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.