510(k) K043261 ยท FMF Syringe, Piston
HARVEST GRAFT DELIVERY SYRINGE
| Applicant | Harvest Technologies, Corp., Plymouth MA, US |
| Decision | Substantially Equivalent, Mar 11, 2005 |
| Received | Nov 24, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K043261
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 20, 2017 | Terumo BCT, Inc. HARVEST TERUMOBCT, GCP-10 Graft Delivery Pack, REF 51449, Rx Only, STERILE EO
Harvest Graph Delivery System is a disposable pack that takes the cell concentrate created while using the BMAC Procedure Terminated |
FMF | None listed |
| Oct 17, 2013 | Harvest Technologies Corporation Harvest Graft Delivery System; Model Number: GDP-10
Product Usage: The Harvest Graft Delivery System is intended for the aspiration of bone marrow, autologous blood, plasma, or other body fluids. Th Terminated |
FMF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.