The following data is part of a premarket notification filed by American Edwards Laboratories with the FDA for Swan-ganz Flow-directed Thermodilution.
| Device ID | K810352 |
| 510k Number | K810352 |
| Device Name: | SWAN-GANZ FLOW-DIRECTED THERMODILUTION |
| Classification | Catheter, Flow Directed |
| Applicant | AMERICAN EDWARDS LABORATORIES 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 | 1981-02-10 |
| Decision Date | 1981-03-27 |