510(k) K001063

SWAN-GANZ SYNTHETIC CONTROLCATH THERMODILUTION CATHETERS, MODELS C146F7, C146HF7, S146F7, S146HF7 by Baxter Healthcare Corp — Product Code DYG

K001063 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "SWAN-GANZ SYNTHETIC CONTROLCATH THERMODILUTION CATHETERS, MODELS C146F7, C146HF7, S146F7, S146HF7". The FDA issued a decision of Substantially Equivalent on July 7, 2000. The device falls under product code DYG (Catheter, Flow Directed), a Class II device regulated under 21 CFR 870.1240. Baxter Healthcare Corp has at least 10 other 510(k) clearances on record.