The following data is part of a premarket notification filed by Texas Medical Products, Inc. with the FDA for Cardioplegic Sets.
| Device ID | K802545 |
| 510k Number | K802545 |
| Device Name: | CARDIOPLEGIC SETS |
| Classification | Heat-exchanger, Cardiopulmonary Bypass |
| Applicant | TEXAS MEDICAL PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DTR |
| CFR Regulation Number | 870.4240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-10-15 |
| Decision Date | 1981-01-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B0664110090003 | K802545 | 000 |
| B0664110100000 | K802545 | 000 |
| B0664110080007 | K802545 | 000 |
| B0664110070000 | K802545 | 000 |
| B0664110060000 | K802545 | 000 |
| B0664110050000 | K802545 | 000 |