The following data is part of a premarket notification filed by Texas Medical Products, Inc. with the FDA for Quickie Prime Cardiop. Bypass Perf. Intr.
| Device ID | K801402 |
| 510k Number | K801402 |
| Device Name: | QUICKIE PRIME CARDIOP. BYPASS PERF. INTR |
| 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 |
|---|---|---|
| B0663011320006 | K801402 | 000 |
| B0663011340006 | K801402 | 000 |
| B066301011NS3 | K801402 | 000 |
| B0663011240000 | K801402 | 000 |
| B0663010120007 | K801402 | 000 |
| B0663010110000 | K801402 | 000 |
| B066301103NS5 | K801402 | 000 |
| B066301172NS1 | K801402 | 000 |
| B066301012NS1 | K801402 | 000 |