K830634 is an FDA 510(k) clearance for the CARDIOTOMY FILTER. This device is classified as a Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass (Class II - Special Controls, product code JOD).
Submitted by Texas Medical Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 30, 1983, 121 days after receiving the submission on March 1, 1983.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4270.
| 510(k) Number | K830634 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 01, 1983 |
| Decision Date | June 30, 1983 |
| Days to Decision | 121 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | JOD — Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4270 |