The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Swan-ganz Continuous Cardiac Output/oximetry/venous Port.
| Device ID | K934742 |
| 510k Number | K934742 |
| Device Name: | SWAN-GANZ CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VENOUS PORT |
| Classification | Catheter, Flow Directed |
| Applicant | BAXTER HEALTHCARE CORP. P.O. BOX 11150 Santa Ana, CA 92711 |
| Contact | Irene Ponzoa Parker |
| Correspondent | Irene Ponzoa Parker 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 | 1993-10-04 |
| Decision Date | 1994-01-24 |