K921994 is an FDA 510(k) clearance for the BARD PCA II PUMP WITH PROGRAM CARTRIDGES. This device is classified as a Pump, Infusion, Pca (Class II - Special Controls, product code MEA).
Submitted by C.R. Bard, Inc. (North Reading, US). The FDA issued a Cleared decision on August 3, 1992, 97 days after receiving the submission on April 28, 1992.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K921994 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 28, 1992 |
| Decision Date | August 03, 1992 |
| Days to Decision | 97 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | MEA — Pump, Infusion, Pca |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5725 |