510(k) K082847

PINNACLE ROII INTRODUCER SHEATH by Terumo Medical Corp. — Product Code DYB

K082847 is an FDA 510(k) premarket notification submitted by Terumo Medical Corp. for the device "PINNACLE ROII INTRODUCER SHEATH". The FDA issued a decision of Substantially Equivalent on October 29, 2008. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Terumo Medical Corp. has at least 10 other 510(k) clearances on record.