510(k) K130394 ยท MEA Pump, Infusion, Pca
CADD -SOLIS AMBULATORY INFUSION PUMP, VERSION 3.0
| Applicant | Smiths Medical Asd, Inc., St. Paul MN, US |
| Decision | Substantially Equivalent, Dec 9, 2013 |
| Received | Feb 15, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K130394
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 7, 2025 | Smiths Medical ASD, Inc. CADD-Solis HPCA Ambulatory Infusion Pump;
Model/Number:
21-2111-0402-09-KYO
21-2111-0402-09-KYO
CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP
21-2111-0300-09_LOAN
CADD SOLIS PIB PUMP FOR CLI Open, Classified |
MEA | None listed |
| Jun 18, 2015 | Smiths Medical ASD, Inc. CADD- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0.
Provide measured drug therapy to patients in hospital or outpatient sett Terminated |
MEA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.