510(k) K915522 ยท FRN Pump, Infusion
FLO-GARD(R) 6201
| Applicant | Baxter Healthcare Corp, Round Lake IL, US |
| Decision | Substantially Equivalent, Feb 28, 1992 |
| Received | Dec 10, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K915522
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 29, 2011 | Baxter Healthcare Corp. Baxter Flo-Gard 6201, Single Channel Volumetric Infusion Pump; Baxter Healthcare Corporation, Deerfield, IL 60015; Product Code # 2M8063
The Flo-Gard Volumetric Infusion Pumps are an electromechanica Terminated |
FRN | None listed |
| Jan 21, 2011 | Baxter Healthcare Corp. Baxter FloGard 6201 Volumetric Infusion Pump. Baxter Healthcare Corporation, Medication Delivery Division. Product code 2M8063
For delivery of intravenous solutions, drug solutions, enteral feedings Terminated |
FRN | None listed |
| Jul 28, 2007 | Baxter Healthcare Corp. Baxter Flo-Gard 6201, SIngle Channel , Volumetric Infusion Pump; Baxter Healthcare Corporation, Deerfield, IL 60015; Product Code # 2M8063 Terminated |
FRN | None listed |
| Mar 20, 2007 | Baxter Healthcare Corp. Baxter Flo-Gard 6201 Volumetric Infusion Pump, catalog #2M8063, 2M8063R (refurbished); Baxter Healthcare Corporation, Deerfield, IL 60015 Terminated |
FRN | None listed |
| Sep 21, 2005 | Baxter Healthcare Corp. Baxter Flo-Gard 6201 Volumetric Infusion Pump, catalog #2M8063, 2M8063R (refurbished), 2M8063G (global), 2M8063U, 2M8063F, 2M8063A, 2M8063D & 2M8063B; Baxter Healthcare Corporation, Deerfield, IL 6001 Terminated |
FRN | None listed |
| Sep 21, 2005 | Baxter Healthcare Corp. Baxter Flo-Gard 6301 Dual Channel Volumetric Infusion Pump, catalog #2M8064, 2M8064R (refurbished), 2M8064G, 2M8064U, 2M8064F, 2M8064A, 2M8064D & 2M8064B; Baxter Healthcare Corporation, Deerfield, IL Terminated |
FRN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.