K931113 is an FDA 510(k) clearance for the CADD-TPN(TM) AMBULATORY INFUSION SYSTEM. This device is classified as a Pump, Infusion Or Syringe, Extra-luminal (Class II - Special Controls, product code FIH).
Submitted by Pharmacia Deltec, Inc. (St. Paul, US). The FDA issued a Cleared decision on April 28, 1994, 420 days after receiving the submission on March 4, 1993.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K931113 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 04, 1993 |
| Decision Date | April 28, 1994 |
| Days to Decision | 420 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FIH — Pump, Infusion Or Syringe, Extra-luminal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5820 |