The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Swan-ganz Thermodilution Ejection Fraction/volume.
| Device ID | K896466 |
| 510k Number | K896466 |
| Device Name: | SWAN-GANZ THERMODILUTION EJECTION FRACTION/VOLUME |
| Classification | Catheter, Flow Directed |
| Applicant | BAXTER HEALTHCARE CORP. P.O. BOX 11150 Santa Ana, CA 92711 |
| Contact | M Taflinger |
| Correspondent | M Taflinger BAXTER HEALTHCARE CORP. P.O. BOX 11150 Santa Ana, CA 92711 |
| Product Code | DYG |
| CFR Regulation Number | 870.1240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-11-13 |
| Decision Date | 1990-02-08 |