The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Swan-ganz(r) Flow Direct Oximetry/thermod Cather.
| Device ID | K905458 |
| 510k Number | K905458 |
| Device Name: | SWAN-GANZ(R) FLOW DIRECT OXIMETRY/THERMOD CATHER |
| Classification | Catheter, Oximeter, Fiber-optic |
| Applicant | BAXTER HEALTHCARE CORP. 17221 RED HILL AVE. PO BOX 11150 Irvine, CA 92614 -5627 |
| Contact | Jack P Douglas |
| Correspondent | Jack P Douglas BAXTER HEALTHCARE CORP. 17221 RED HILL AVE. PO BOX 11150 Irvine, CA 92614 -5627 |
| Product Code | DQE |
| CFR Regulation Number | 870.1230 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-12-05 |
| Decision Date | 1991-02-07 |