The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Swan-ganz Synthetic Controlcath Thermodilution Catheters, Models C146f7, C146hf7, S146f7, S146hf7.
| Device ID | K001063 |
| 510k Number | K001063 |
| Device Name: | SWAN-GANZ SYNTHETIC CONTROLCATH THERMODILUTION CATHETERS, MODELS C146F7, C146HF7, S146F7, S146HF7 |
| Classification | Catheter, Flow Directed |
| Applicant | BAXTER HEALTHCARE CORP. 17221 RED HILL AVE. PO BOX 11150 Irvine, CA 92614 -5627 |
| Contact | Jason Smith |
| Correspondent | Jason Smith BAXTER HEALTHCARE CORP. 17221 RED HILL AVE. PO BOX 11150 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 | 2000-04-03 |
| Decision Date | 2000-07-07 |