The following data is part of a premarket notification filed by Smiths Medical Asd, Inc. with the FDA for Cadd -solis Ambulatory Infusion Pump, Version 3.0.
| Device ID | K130394 |
| 510k Number | K130394 |
| Device Name: | CADD -SOLIS AMBULATORY INFUSION PUMP, VERSION 3.0 |
| Classification | Pump, Infusion, Pca |
| Applicant | SMITHS MEDICAL ASD, INC. 1265 GREY FOX ROAD St. Paul, MN 55112 |
| Contact | Paula Cordero |
| Correspondent | Paula Cordero SMITHS MEDICAL ASD, INC. 1265 GREY FOX ROAD St. Paul, MN 55112 |
| Product Code | MEA |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-15 |
| Decision Date | 2013-12-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00610586018636 | K130394 | 000 |
| 10610586038815 | K130394 | 000 |
| 10610586038822 | K130394 | 000 |
| 10610586042720 | K130394 | 000 |
| 10610586042737 | K130394 | 000 |
| 10610586044168 | K130394 | 000 |
| 10610586045387 | K130394 | 000 |
| 10610586034992 | K130394 | 000 |
| 10610586038778 | K130394 | 000 |
| 10610586038808 | K130394 | 000 |
| 10610586038785 | K130394 | 000 |