510(k) K982797

BLUNT T-PEEL INTRODUCER MODEL NUMBER PE-16PICB, PE-18PICB, PE-20PICB, PE-24PICB by Luther Medical Products, Inc. — Product Code DYB

K982797 is an FDA 510(k) premarket notification submitted by Luther Medical Products, Inc. for the device "BLUNT T-PEEL INTRODUCER MODEL NUMBER PE-16PICB, PE-18PICB, PE-20PICB, PE-24PICB". The FDA issued a decision of Substantially Equivalent on November 30, 1998. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Luther Medical Products, Inc. has at least 10 other 510(k) clearances on record.