510(k) K122262 ยท CAC Apparatus, Autotransfusion
ORTHOPAT ADVANCE PERIOPERATIVE AUTOTRANSFUSION SYSTEM
| Applicant | Haemonetics Corp., El Dorado Hills CA, US |
| Decision | Substantially Equivalent, Oct 25, 2012 |
| Received | Jul 27, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K122262
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 13, 2018 | Haemonetics Corporation Haemonetics OrthoPAT System-OPAT QuickConnect Reservoirs.
Product Code: OPT-R-1000
The OrthoPAT orthopedic perioperative autotransfusion system indicated for use to salvage RBCs from blood lost intra Terminated |
CAC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.