K904040 is an FDA 510(k) clearance for the SOFTSHELL VENOUS RESERVOIR. This device is classified as a Reservoir, Blood, Cardiopulmonary Bypass (Class II - Special Controls, product code DTN).
Submitted by C.R. Bard, Inc. (Tewksbury, US). The FDA issued a Cleared decision on December 6, 1990, 93 days after receiving the submission on September 4, 1990.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4400.
| 510(k) Number | K904040 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 04, 1990 |
| Decision Date | December 06, 1990 |
| Days to Decision | 93 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DTN — Reservoir, Blood, Cardiopulmonary Bypass |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4400 |