The following data is part of a premarket notification filed by Norton Texas Medical Products with the FDA for Myocardial Insulator.
| Device ID | K843983 |
| 510k Number | K843983 |
| Device Name: | MYOCARDIAL INSULATOR |
| Classification | Heat-exchanger, Cardiopulmonary Bypass |
| Applicant | NORTON TEXAS MEDICAL PRODUCTS 10940 SOUTH WILCREST DR. Houston, TX 77099 |
| Contact | Rick Foster |
| Correspondent | Rick Foster NORTON TEXAS MEDICAL PRODUCTS 10940 SOUTH WILCREST DR. Houston, TX 77099 |
| Product Code | DTR |
| CFR Regulation Number | 870.4240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-10-11 |
| Decision Date | 1984-12-27 |