The following data is part of a premarket notification filed by Texas Medical Products, Inc. with the FDA for Cardiotomy Filter.
| Device ID | K830634 |
| 510k Number | K830634 |
| Device Name: | CARDIOTOMY FILTER |
| Classification | Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass |
| Applicant | TEXAS MEDICAL PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JOD |
| CFR Regulation Number | 870.4270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-03-01 |
| Decision Date | 1983-06-30 |