The following data is part of a premarket notification filed by Sorensen Research with the FDA for Flow-directed Thermodilution Catheter.
| Device ID | K812324 |
| 510k Number | K812324 |
| Device Name: | FLOW-DIRECTED THERMODILUTION CATHETER |
| Classification | Catheter, Flow Directed |
| Applicant | SORENSEN RESEARCH 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DYG |
| CFR Regulation Number | 870.1240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-08-17 |
| Decision Date | 1981-09-25 |