510(k) K132730

BIO-PROBE DISPOSABLE INSERT WITH; BALANCE BIOSURFACE, CARMEDA BIOACTIVE SURFACE, TRILLIUM BIOSURFACE by Medtronic, Inc. — Product Code DPT

K132730 is an FDA 510(k) premarket notification submitted by Medtronic, Inc. for the device "BIO-PROBE DISPOSABLE INSERT WITH; BALANCE BIOSURFACE, CARMEDA BIOACTIVE SURFACE, TRILLIUM BIOSURFACE". The FDA issued a decision of Substantially Equivalent on May 30, 2014. The device falls under product code DPT (Probe, Blood-Flow, Extravascular), a Class II device regulated under 21 CFR 870.2120. Medtronic, Inc. has at least 10 other 510(k) clearances on record.