510(k) K980487

CARPENTER-EDWARDS CLASSIC RING WITH DURAFLO TREATMENT MODELS 4425 (MITRAL) AND 4525 (TRICUSPID), CARPENTER-EDWARDS PHYSM by Baxter Edwards — Product Code KRH

K980487 is an FDA 510(k) premarket notification submitted by Baxter Edwards for the device "CARPENTER-EDWARDS CLASSIC RING WITH DURAFLO TREATMENT MODELS 4425 (MITRAL) AND 4525 (TRICUSPID), CARPENTER-EDWARDS PHYSM". The FDA issued a decision of Substantially Equivalent on July 7, 1998. The device falls under product code KRH (Ring, Annuloplasty), a Class II device regulated under 21 CFR 870.3800. Baxter Edwards has at least 10 other 510(k) clearances on record.