510(k) K905175

PTI ANNULOPLASTY RING(STERILE) by Pioneering Technologies, Inc. — Product Code KRH

K905175 is an FDA 510(k) premarket notification submitted by Pioneering Technologies, Inc. for the device "PTI ANNULOPLASTY RING(STERILE)". The FDA issued a decision of Substantially Equivalent on February 14, 1992. The device falls under product code KRH (Ring, Annuloplasty), a Class II device regulated under 21 CFR 870.3800. Pioneering Technologies, Inc. has at least 10 other 510(k) clearances on record.