The following data is part of a premarket notification filed by Texas Medical Products, Inc. with the FDA for Disposable Sump Sets.
| Device ID | K801392 |
| 510k Number | K801392 |
| Device Name: | DISPOSABLE SUMP SETS |
| 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 | 1980-06-13 |
| Decision Date | 1980-06-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B0662010950006 | K801392 | 000 |
| B0662010890006 | K801392 | 000 |
| B0662010440006 | K801392 | 000 |