The following data is part of a premarket notification filed by Texas Medical Products, Inc. with the FDA for Disposable 2-stage Cannula.
| Device ID | K810515 |
| 510k Number | K810515 |
| Device Name: | DISPOSABLE 2-STAGE CANNULA |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | TEXAS MEDICAL PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-02-25 |
| Decision Date | 1981-04-23 |