K862836 is an FDA 510(k) clearance for the STOCKERT-SHILEY CAPS AND CAPS DUAL PRESSURE MODULE. This device is classified as a Gauge, Pressure, Coronary, Cardiopulmonary Bypass (Class II - Special Controls, product code DXS).
Submitted by Shiley, Inc. (Irvine, US). The FDA issued a Cleared decision on September 12, 1986, 49 days after receiving the submission on July 25, 1986.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4310.
| 510(k) Number | K862836 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 25, 1986 |
| Decision Date | September 12, 1986 |
| Days to Decision | 49 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DXS — Gauge, Pressure, Coronary, Cardiopulmonary Bypass |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4310 |