510(k) K123591

FLEXCATH ADVANCE STEERABLE SHEATH (12 FRENCH) by Medtronic Cryocath, LP — Product Code DRA

K123591 is an FDA 510(k) premarket notification submitted by Medtronic Cryocath, LP for the device "FLEXCATH ADVANCE STEERABLE SHEATH (12 FRENCH)". The FDA issued a decision of Substantially Equivalent on December 27, 2012. The device falls under product code DRA (Catheter, Steerable), a Class II device regulated under 21 CFR 870.1280. Medtronic Cryocath, LP has at least 5 other 510(k) clearances on record.