510(k) K923367

COSGROVE EDWARDS ANNULOPLASTY SYSTEM, MODEL 4600 by Baxter Healthcare Corp — Product Code KRH

K923367 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "COSGROVE EDWARDS ANNULOPLASTY SYSTEM, MODEL 4600". The FDA issued a decision of Substantially Equivalent - Postmarket Surveillance Required on Jan 6, 1993. The device falls under product code KRH (Ring, Annuloplasty), a Class II device regulated under 21 CFR 870.3800. Baxter Healthcare Corp has 507 other 510(k) clearances on record.