The following data is part of a premarket notification filed by Texas Medical Products, Inc. with the FDA for Cardiopulmonary Bypass Pump Tubing.
| Device ID | K801394 |
| 510k Number | K801394 |
| Device Name: | CARDIOPULMONARY BYPASS PUMP TUBING |
| Classification | Tubing, Pump, Cardiopulmonary Bypass |
| Applicant | TEXAS MEDICAL PRODUCTS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DWE |
| CFR Regulation Number | 870.4390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-06-13 |
| Decision Date | 1980-06-30 |