510(k) K063530 ยท MEB Pump, Infusion, Elastomeric
ON-Q, PAINBUSTER, C-BLOC, SELECT-A-FLOW, ONDEMAND, HOMEPUMP, ECLIPSE, C-SERIES, ONE-STEP KVO, EASYPUMP
| Applicant | I-Flow Corp., Lake Forest CA, US |
| Decision | Substantially Equivalent, Jan 26, 2007 |
| Received | Nov 22, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K063530
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 28, 2011 | I-Flow Corporation I-Flow ON-Q with Select-A-Flow Pumps,
Intended for continuous and/or intermittent delivery of medication to and around surgical wound sites and/or close proximity to nerves for preoperative, periope Terminated |
MEB | None listed |
| Sep 11, 2008 | I-Flow Corporation ON-Q PainBuster Infusion Pump (270 ml, 5 ml/hr), REF PS6504, Part No. 5001260. The pump is indicated for continuous and/or intermittent delivery of medication (such as local anesthetics or narcotics) Terminated |
MEB | None listed |
| Sep 11, 2008 | I-Flow Corporation On-Q C-bloc 400 ml, 1-7 ml/hr Select-A-Flow + 5 ml/60 min ONDEMAND, REF CB005 indicated for continuous and/or intermittent delivery of medication (such as local anesthetics or narcotics) to or around Terminated |
MEB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.