510(k) K102176

FLEXCATH STEERABLE SHEATH (12 FRENCH), FLEXCATH STEERABLE SHEATH (10 FRENCH) MODEL 3FC12, 3FC10 by Medtronic Cryocath, LP — Product Code DRA

K102176 is an FDA 510(k) premarket notification submitted by Medtronic Cryocath, LP for the device "FLEXCATH STEERABLE SHEATH (12 FRENCH), FLEXCATH STEERABLE SHEATH (10 FRENCH) MODEL 3FC12, 3FC10". The FDA issued a decision of Substantially Equivalent on September 1, 2010. 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.