The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Swan-ganze Continuous Cardiac Output/oximetry/venous Infusion Port/ejection Fraction/volumetric (cco/svo2/vip/ref) Cath].
| Device ID | K951566 |
| 510k Number | K951566 |
| Device Name: | SWAN-GANZE CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VENOUS INFUSION PORT/EJECTION FRACTION/VOLUMETRIC (CCO/SVO2/VIP/REF) CATH] |
| Classification | Catheter, Flow Directed |
| Applicant | BAXTER HEALTHCARE CORP. P.O. BOX 11150 Santa Ana, CA 92711 |
| Contact | Ric Ruedy |
| Correspondent | Ric Ruedy 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 | 1995-04-04 |
| Decision Date | 1995-11-27 |
| Summary: | summary |