K915737 is an FDA 510(k) clearance for the AUTOTRANSFUSION BLOOD COLLECTION RESERVOIR. This device is classified as a Reservoir, Blood, Cardiopulmonary Bypass (Class II - Special Controls, product code DTN).
Submitted by Electromedics, Inc. (Englewood, US). The FDA issued a Cleared decision on September 3, 1992, 258 days after receiving the submission on December 20, 1991.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4400.
| 510(k) Number | K915737 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 20, 1991 |
| Decision Date | September 03, 1992 |
| Days to Decision | 258 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
| Product Code | DTN — Reservoir, Blood, Cardiopulmonary Bypass |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4400 |