The following data is part of a premarket notification filed by Texas Medical Products, Inc. with the FDA for Disposable Perfusion Set.
| Device ID | K801403 |
| 510k Number | K801403 |
| Device Name: | DISPOSABLE PERFUSION SET |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | TEXAS MEDICAL PRODUCTS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| 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 |
|---|---|---|
| B0663011210006 | K801403 | 000 |
| B0663010280006 | K801403 | 000 |
| B0663010270006 | K801403 | 000 |
| B0663010260006 | K801403 | 000 |
| B0663010220006 | K801403 | 000 |
| B0663010210006 | K801403 | 000 |
| B0663010180006 | K801403 | 000 |
| B066301021NS1 | K801403 | 000 |