510(k) K982838 ยท FRN Pump, Infusion
CADD-LEGACY 1 AMBULATORY INFUSION SYSTEM MODEL NUMBER 6400
| Applicant | Sims Deltec, Inc., St. Paul MN, US |
| Decision | Substantially Equivalent, Nov 4, 1998 |
| Received | Aug 12, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K982838
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 2, 2018 | Smiths Medical ASD Inc. CADD-Legacy 1, Model 6400 Ambulatory Infusion Pump, REF 21-6400-51, PC 10008552-001, Smiths Medical ASD, Inc. Rx ONLY Terminated |
FRN | None listed |
| Apr 5, 2010 | Smiths Medical ASD, Inc. CADD-LEGACY 1 Model 6400, Ambulatory Infusion Pump,
REF 21-6400-51, Rx Only, Smiths Medical MD, Inc.., St. Paul, MN 55112. Terminated |
FRN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.