The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Swan-ganz Intellicath Cco Thermodilution Catheter.
| Device ID | K924661 |
| 510k Number | K924661 |
| Device Name: | SWAN-GANZ INTELLICATH CCO THERMODILUTION CATHETER |
| Classification | Catheter, Continuous Flush |
| Applicant | BAXTER HEALTHCARE CORP. P.O. BOX 11150 Santa Ana, CA 92711 |
| Contact | Foss Davies |
| Correspondent | Foss Davies BAXTER HEALTHCARE CORP. P.O. BOX 11150 Santa Ana, CA 92711 |
| Product Code | KRA |
| CFR Regulation Number | 870.1210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-09-15 |
| Decision Date | 1993-04-08 |