510(k) K062457 ยท MEB Pump, Infusion, Elastomeric
INFUSOR SMALL VOLUME ELASTOMERIC INFUSION DEVICES
| Applicant | Baxter Healthcare Corporation, Mcgaw Park IL, US |
| Decision | Substantially Equivalent, Sep 21, 2006 |
| Received | Aug 23, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K062457
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 27, 2013 | Baxter Healthcare Corp. Brand Name: Coiled Tube Infusors (Portable Elastomeric Infusion Systems). Baxter's Infusor SV Elastomeric Infusion Device
Device Listing: D020871
Baxter's lnfusors SV Elastomeric Infusion Device i Terminated |
MEB | None listed |
| Jan 23, 2008 | Baxter Healthcare Corp. Baxter Single Day INFUSOR Portable Elastomeric Infusion System, Product Code: 2C1071KJP; 2mL/hr with Tubing Flow Restrictor; 12 units per case; Baxter Healthcare Corporation, Deerfield, IL 60015 Terminated |
MEB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.