K892856 is an FDA 510(k) clearance for the NEWMARK(TM) CORONARY ARTERY BYPASS GRAFT MARKERS. This device is classified as a Accessory Equipment, Cardiopulmonary Bypass (Class I - General Controls, product code KRI).
Submitted by Acacia Laboratories, Inc. (Santa Ana, US). The FDA issued a Cleared decision on November 8, 1989, 204 days after receiving the submission on April 18, 1989.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4200.
| 510(k) Number | K892856 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 18, 1989 |
| Decision Date | November 08, 1989 |
| Days to Decision | 204 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | KRI — Accessory Equipment, Cardiopulmonary Bypass |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 870.4200 |