510(k) K992723 ยท CAC Apparatus, Autotransfusion
ORTHOPEDIC PERIOPERATIVE AUTOTRANSFUSION (ORTHOPAT) SYSTEM
| Applicant | Transfusion Technologies Corp., Natick MA, US |
| Decision | Substantially Equivalent, Oct 18, 1999 |
| Received | Aug 13, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K992723
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 13, 2018 | Haemonetics Corporation Haemonetics OrthoPAT System-Integrated Set.
Product Code: 1150H-00
OrthoPAT orthopedic perioperative autotransfusion system indicated for use to salvage RBCs from blood lost intraoperatively and pos Terminated |
CAC | None listed |
| Jun 7, 2011 | Haemonetics Corporation Haemonetics OrthoPAT -Orthopedic Perioperative Autotransfusion System
US Only: 1050-110-ENG
Outside US:
1050-110-ENG, I050-240-XXX (generic), 1050-240-ENG, 1050-240-SPN, 1050-240-ITL, 1050-240GER,
105 Terminated |
CAC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.