510(k) K101907 ยท CAC Apparatus, Autotransfusion
HAEMONETICS CELL SAVER ELITE AUTOTRANSFUSION SYSTEM
| Applicant | Haemonetics Corp., Braintree MA, US |
| Decision | Substantially Equivalent, Dec 3, 2010 |
| Received | Jul 8, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101907
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 21, 2019 | Haemonetics Corporation CS Elite Processing Set (225 ml) Autotransfusion Device - Product Usage:its related accessory components are intended for use to recover blood shed during or subsequent to an operation or as a result Terminated |
CAC | None listed |
| Oct 21, 2019 | Haemonetics Corporation CS Elite Processing Set (125 ml) Autotransfusion Device - Product Usage:its related accessory components are intended for use to recover blood shed during or subsequent to an operation or as a result Terminated |
CAC | None listed |
| Oct 21, 2019 | Haemonetics Corporation CS Elite Fastpack, 225 mL, 20 Res Autotransfusion Device - Product Usage: its related accessory components are intended for use to recover blood shed during or subsequent to an operation or as a resul Terminated |
CAC | None listed |
| Oct 21, 2019 | Haemonetics Corporation CS Elite Fastpack, 225 mL, 150 Res Autotransfusion Device - Product Usage: its related accessory components are intended for use to recover blood shed during or subsequent to an operation or as a resu Terminated |
CAC | None listed |
| Oct 21, 2019 | Haemonetics Corporation CS Elite Fastpack, 125 mL, 150 Res Autotransfusion Device - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent t Terminated |
CAC | None listed |
| Aug 2, 2017 | Haemonetics Corporation Cell Saver Elite Processing Kit, 70 ml, Product ID: CSE-P-70
Indications for Use: The Haemonetics Cell Saver 5/5+ System and its related accessory components are intended to be used for the recovery Terminated |
CAC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.