510(k) K003616 ยท FRN Pump, Infusion
COLLEAGUE (3CX, 3, CX) VOLUMETRIC INFUSION PUMP
| Applicant | Baxter Healthcare Corp, Round Lake IL, US |
| Decision | Substantially Equivalent, Dec 12, 2000 |
| Received | Nov 22, 2000 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K003616
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 22, 2004 | Baxter Healthcare Corp. Colleague 3 Triple Channel Volumetric Infusion Pumps, product code 2M8153 and 2M8153R; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in Singapore; monochrome display screen Terminated |
FRN | None listed |
| Dec 22, 2004 | Baxter Healthcare Corp. Colleague CX Single Channel Volumetric Infusion Pumps, product code 2M8161and 2M8161R; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in Singapore; color display screen Terminated |
FRN | None listed |
| Dec 22, 2004 | Baxter Healthcare Corp. Colleague 3 CX Triple Channel Volumetric Infusion Pumps, product code 2M8163 and 2M8163R; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in Singapore; color display screen Terminated |
FRN | None listed |
| Jul 20, 2004 | Baxter Healthcare Corp. Colleague 3 Triple Channel Volumetric Infusion Pumps, product code 2M8153 and 2M8153K (United Kingdom); Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in Singapore; monochrome display Terminated |
FRN | None listed |
| Jul 20, 2004 | Baxter Healthcare Corp. Colleague CX Single Channel Volumetric Infusion Pumps, product code 2M8161; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in Singapore; color display screen Terminated |
FRN | None listed |
| Jul 20, 2004 | Baxter Healthcare Corp. Colleague 3 CX Triple Channel Volumetric Infusion Pumps, product code 2M8163; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in Singapore; color display screen Terminated |
FRN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.