510(k) K914972

CARPENTIER-EDWARDS(R) FLEX ANNUL RING, 4500 TRICUS by Baxter Healthcare Corp — Product Code KRH

K914972 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "CARPENTIER-EDWARDS(R) FLEX ANNUL RING, 4500 TRICUS". The FDA issued a decision of Substantially Equivalent on Jan 9, 1992. 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.