The following data is part of a premarket notification filed by Texas Medical Products, Inc. with the FDA for Disposable Sucker System.
| Device ID | K801400 |
| 510k Number | K801400 |
| Device Name: | DISPOSABLE SUCKER SYSTEM |
| Classification | Sucker, Cardiotomy Return, Cardiopulmonary Bypass |
| Applicant | TEXAS MEDICAL PRODUCTS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DTS |
| CFR Regulation Number | 870.4420 [🔎] |
| 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 |
|---|---|---|
| B0662013010006 | K801400 | 000 |
| B066201280NS1 | K801400 | 000 |
| B066201190NS1 | K801400 | 000 |
| B066201180NS3 | K801400 | 000 |
| B066201164NS3 | K801400 | 000 |
| B066201135NS1 | K801400 | 000 |
| B066201090NS3 | K801400 | 000 |
| B066201080NS3 | K801400 | 000 |
| B066201037NS3 | K801400 | 000 |
| B066201301NS1 | K801400 | 000 |
| B0662010350006 | K801400 | 000 |
| B0662012800006 | K801400 | 000 |
| B0662011900006 | K801400 | 000 |
| B0662011800006 | K801400 | 000 |
| B0662011640006 | K801400 | 000 |
| B0662011350006 | K801400 | 000 |
| B0662010900006 | K801400 | 000 |
| B0662010370006 | K801400 | 000 |
| B0662010360006 | K801400 | 000 |
| B066201035NS3 | K801400 | 000 |