K982891 is an FDA 510(k) clearance for the CALIFORNIA MEDICAL LABORATORIES INC. STANDARD AND SMALL RIGID TIP SUCTION WANDS. This device is classified as a Sucker, Cardiotomy Return, Cardiopulmonary Bypass (Class II - Special Controls, product code DTS).
Submitted by California Medical Laboratories, Inc. (Irvine, US). The FDA issued a Cleared decision on September 30, 1998, 44 days after receiving the submission on August 17, 1998.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4420.
| 510(k) Number | K982891 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 17, 1998 |
| Decision Date | September 30, 1998 |
| Days to Decision | 44 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DTS — Sucker, Cardiotomy Return, Cardiopulmonary Bypass |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4420 |