510(k) K991513 ยท FPA Set, Administration, Intravascular
HOMEPUMP C-SERIES AND HOMEPUMP C-SERIES ONE-STEP KVO
| Applicant | I-Flow Corp., Lake Forest CA, US |
| Decision | Substantially Equivalent, Jun 21, 1999 |
| Received | Apr 30, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K991513
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 18, 2003 | I-Flow Corporation Easypump LT 60-24
Easypump Infusion Pump (60 ml x 2 ml/hr) Terminated |
None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.