510(k) K101150

PICC WAND PEELABLE SAFETY INTRODUCER by Access Scientific, Inc. — Product Code DYB

K101150 is an FDA 510(k) premarket notification submitted by Access Scientific, Inc. for the device "PICC WAND PEELABLE SAFETY INTRODUCER". The FDA issued a decision of Substantially Equivalent on August 13, 2010. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Access Scientific, Inc. has at least 10 other 510(k) clearances on record.