K993060 is an FDA 510(k) clearance for the GAS FILTER. This device is classified as a Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass (Class II - Special Controls, product code JOD).
Submitted by Olson Medical Sales, Inc. (Somerset, US). The FDA issued a Cleared decision on March 28, 2000, 197 days after receiving the submission on September 13, 1999.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4270.
| 510(k) Number | K993060 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 13, 1999 |
| Decision Date | March 28, 2000 |
| Days to Decision | 197 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | JOD — Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4270 |