510(k) K043127 ยท CAC Apparatus, Autotransfusion
HAEMONETICS CARDIOVASCULAR PERIOPERATIVE AUTOTRANSFUSION SYSTEM
| Applicant | Haemonetics Corp., Braintree MA, US |
| Decision | Substantially Equivalent, Jan 4, 2005 |
| Received | Nov 12, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K043127
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 23, 2005 | Haemonetics Corporation cardioPAT Cardiovascular Perioperative Autotransfusion System, Model: LN 2050-110-E
and Disposables:
cardioPAT Replacement RBC Bags, LN 00270
cardioPAT Replacement Waste Bags, LN 00271
cardioPAT Repl Terminated |
CAC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.