The following data is part of a premarket notification filed by Baxter Edwards with the FDA for Swan-ganz Cc0/svo2 Thermodilution Catheter.
| Device ID | K940795 |
| 510k Number | K940795 |
| Device Name: | SWAN-GANZ CC0/SVO2 THERMODILUTION CATHETER |
| Classification | Catheter, Flow Directed |
| Applicant | BAXTER EDWARDS 17221 RED HILL AVE. Irvine, CA 92614 -5627 |
| Contact | Irene Parker |
| Correspondent | Irene Parker BAXTER EDWARDS 17221 RED HILL AVE. Irvine, CA 92614 -5627 |
| Product Code | DYG |
| CFR Regulation Number | 870.1240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-02-22 |
| Decision Date | 1994-05-24 |