The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Swan-ganz(r) Hi-shore(r) Thermo Cath W/amc(tm).
| Device ID | K910204 |
| 510k Number | K910204 |
| Device Name: | SWAN-GANZ(R) HI-SHORE(R) THERMO CATH W/AMC(TM) |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | BAXTER HEALTHCARE CORP. P.O. BOX 11150 Santa Ana, CA 92711 |
| Contact | Nancly E Shadforth |
| Correspondent | Nancly E Shadforth BAXTER HEALTHCARE CORP. P.O. BOX 11150 Santa Ana, CA 92711 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-16 |
| Decision Date | 1991-04-24 |