510(k) K000842 ยท FRN Pump, Infusion
CADD-PRIZM PCS II MODEL 6101 AMBULATORY INFUSION SYSTEM
| Applicant | Sims Deltec, Inc., St. Paul MN, US |
| Decision | Substantially Equivalent, Jun 8, 2000 |
| Received | Mar 15, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K000842
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 5, 2007 | Smiths Medical MD, Inc. Deltec branded CADD-Prizm PCS II ambulatory infusion pump and the CADD-Prizm VIP system ambulatory infusion pumps; (Both) Model 6101; Order #21-8861-01 (PCS II) and 21-8821-01 (VIP). Smiths Medical MD Terminated |
FRN | None listed |
| Jul 3, 2003 | Deltec, Inc Deltec CADD-Prizm PCS II Ambulatory Infusion Pump with Revision E Software Terminated |
FRN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.