K871221 is an FDA 510(k) clearance for the CDI(TM) EXTRACORPOREAL BLOOD GAS SYSTEM 300. This device is classified as a Monitor, Blood-gas, On-line, Cardiopulmonary Bypass (Class II - Special Controls, product code DRY).
Submitted by Cardiovascular Devices, Inc. (Irvine, US). The FDA issued a Cleared decision on June 5, 1987, 70 days after receiving the submission on March 27, 1987.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4330.
| 510(k) Number | K871221 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 27, 1987 |
| Decision Date | June 05, 1987 |
| Days to Decision | 70 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DRY — Monitor, Blood-gas, On-line, Cardiopulmonary Bypass |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4330 |