The following data is part of a premarket notification filed by Intec Medical, Inc. with the FDA for Interflo Medical Model F-1 Thermodilution Catheter.
| Device ID | K900710 |
| 510k Number | K900710 |
| Device Name: | INTERFLO MEDICAL MODEL F-1 THERMODILUTION CATHETER |
| Classification | Probe, Thermodilution |
| Applicant | INTEC MEDICAL, INC. 1101 RESOURCE DR. SUITE 121 Plano, TX 75074 |
| Contact | Yelderman, M.d. |
| Correspondent | Yelderman, M.d. INTEC MEDICAL, INC. 1101 RESOURCE DR. SUITE 121 Plano, TX 75074 |
| Product Code | KRB |
| CFR Regulation Number | 870.1915 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-02-14 |
| Decision Date | 1990-10-19 |