510(k) K861951

MODIFIED TELEFLEX MEDICAL INTRODUCER CATHETER by Teleflex, Inc. — Product Code DYB

K861951 is an FDA 510(k) premarket notification submitted by Teleflex, Inc. for the device "MODIFIED TELEFLEX MEDICAL INTRODUCER CATHETER". The FDA issued a decision of Substantially Equivalent on June 19, 1986. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Teleflex, Inc. has at least 9 other 510(k) clearances on record.