K801641 is an FDA 510(k) clearance for the OHIO DISPOSABLE CLEAR SUCTION INSTRUMENT. This device is classified as a Sucker, Cardiotomy Return, Cardiopulmonary Bypass (Class II - Special Controls, product code DTS).
Submitted by Ohio Medical Products (Mchenry, US). The FDA issued a Cleared decision on July 28, 1980, 11 days after receiving the submission on July 17, 1980.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4420.
| 510(k) Number | K801641 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 17, 1980 |
| Decision Date | July 28, 1980 |
| Days to Decision | 11 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DTS — Sucker, Cardiotomy Return, Cardiopulmonary Bypass |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4420 |