510(k) K810079 ยท KRI Accessory Equipment, Cardiopulmonary Bypass
SARNS INTEGRATED CARDIOPLEGIA DELIV. SYS
| Applicant | 3M Health Care, Sarns, Mchenry IL, US |
| Decision | Substantially Equivalent, Jan 30, 1981 |
| Received | Jan 13, 1981 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K810079
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 31, 2014 | Terumo Cardiovascular Systems Corp Terumo Custom Integrated Cardioplegia Delivery Set-LINE FOR 15501/16015/5852
Item Number: 16110
Product Usage: This is a replacement line to multiple Cardioplegia Delivery Sets - and includes th Terminated |
KRI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.