K902613 is an FDA 510(k) clearance for the BARD PCA II PUMP WITH PROGRAM CARTRIDGES. This device is classified as a Pump, Infusion (Class II - Special Controls, product code FRN).
Submitted by C.R. Bard, Inc. (North Reading, US). The FDA issued a Cleared decision on April 19, 1991, 310 days after receiving the submission on June 13, 1990.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K902613 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 13, 1990 |
| Decision Date | April 19, 1991 |
| Days to Decision | 310 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | FRN — Pump, Infusion |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5725 |