510(k) K982102 ยท MEB Pump, Infusion, Elastomeric
SINGLEDAY INFUSOR 2 ML/HR (ELASTOMERIC INFUSION DEVICE) MODEL, INFUSOR SV 5 ML/HR (ELASTOMERIC INFUSION DEVICE) MODEL CY
| Applicant | Baxter Healthcare Corp, Round Lake IL, US |
| Decision | Substantially Equivalent, Sep 4, 1998 |
| Received | Jun 15, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K982102
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 5, 2011 | Baxter Healthcare Corp. Baxter Single Day Infusor 2 mL/h Portable Elastomeric Infusion System; an Rx sterile disposable drug delivery system; Baxter Healthcare Corporation, Deerfield, IL 60015; REF 2C1071KJP
The Infusor devi Terminated |
MEB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.