K873802 is an FDA 510(k) clearance for the PRESSURE BARRIER KIT CAT. NO. PBK-3. This device is classified as a Gauge, Pressure, Coronary, Cardiopulmonary Bypass (Class II - Special Controls, product code DXS).
Submitted by American Omni Medical, Inc. (Costa Mesa, US). The FDA issued a Cleared decision on November 6, 1987, 49 days after receiving the submission on September 18, 1987.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4310.
| 510(k) Number | K873802 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 18, 1987 |
| Decision Date | November 06, 1987 |
| 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 |