The following data is part of a premarket notification filed by Texas Medical Products, Inc. with the FDA for Disposable Parallel Y Connectors.
| Device ID | K801404 |
| 510k Number | K801404 |
| Device Name: | DISPOSABLE PARALLEL Y CONNECTORS |
| Classification | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass |
| Applicant | TEXAS MEDICAL PRODUCTS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DTL |
| CFR Regulation Number | 870.4290 [🔎] |
| 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 |
|---|---|---|
| B0663212320007 | K801404 | 000 |
| B066321223NS3 | K801404 | 000 |
| B066321244NS3 | K801404 | 000 |
| B066321333NS3 | K801404 | 000 |
| B066321334NS3 | K801404 | 000 |
| B0663212220006 | K801404 | 000 |
| B0663212230007 | K801404 | 000 |
| B0663212240007 | K801404 | 000 |
| B0663212440007 | K801404 | 000 |
| B0663213220000 | K801404 | 000 |
| B0663213320000 | K801404 | 000 |
| B0663213330003 | K801404 | 000 |
| B0663213340005 | K801404 | 000 |
| B0663213430005 | K801404 | 000 |
| B0663213440007 | K801404 | 000 |
| B0663214420007 | K801404 | 000 |
| B0663214430007 | K801404 | 000 |
| B0663214440005 | K801404 | 000 |
| B066321222NS3 | K801404 | 000 |