510(k) K880733 ยท FRN Pump, Infusion
BARD PCA II INFUSION PUMP
| Applicant | C.R. Bard, Inc., North Reading MA, US |
| Decision | Substantially Equivalent, Jun 20, 1988 |
| Received | Feb 24, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K880733
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 26, 2006 | Baxter Healthcare Corp. Baxter PCA II Syringe Infusion Pump, product codes 2L3104 and 2L3104R; Baxter Healthcare Corporation, Deerfield, IL 60015 Terminated |
MEA | None listed |
| Mar 24, 2006 | Baxter Healthcare Corp. Baxter Anesthesia Set, product code 2C9216; An Rx sterile, nonpyrogenic fluid pathway, 72'', 1.7 mL Vol., with Luer Lock adapters; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A. Terminated |
FPA | None listed |
| Aug 30, 2005 | Baxter Healthcare Corp. Baxter Tamper Resistant Anti-Siphon PCA Extension Set, 60'', product code 2C9205; An Rx sterile, nonpyrogenic fluid pathway, 60'', 1.2 mL Vol., with Luer Lock adapters; Baxter Healthcare Corporation, Terminated |
FPA | None listed |
| Aug 30, 2005 | Baxter Healthcare Corp. Baxter Tamper Resistant Anti-Siphon PCA Extension Set, 96'', product code 2C9206; An Rx sterile, nonpyrogenic fluid pathway, 96'', 1.6 mL Vol., with Luer Lock adapters; Baxter Healthcare Corporation, Terminated |
FPA | None listed |
| Aug 30, 2005 | Baxter Healthcare Corp. Baxter Tamper Resistant Anti-Siphon Combination Set, 101'', product code 2L3507; An Rx sterile, nonpyrogenic fluid pathway, 101'', 2.5 mL Vol., with male Luer Lock adapter; Baxter Healthcare Corporati Terminated |
FPA | None listed |
| Aug 30, 2005 | Baxter Healthcare Corp. Baxter Extension Set, product code 2C9219; An Rx sterile, nonpyrogenic fluid pathway, 61'', 1.4 mL Vol., with Luer Lock adapters; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A. Terminated |
FPA | None listed |
| Jan 28, 2005 | Baxter Healthcare Corp. Anesthesia Set, product code 2C9216; a sterile fluid path consisting of a 72'' long PVC with DEHP tubing with a green stripe, inner diameter of 0.040'', priming volume 1.7 mL, with a luerlock connect Terminated |
FRN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.