510(k) K934901

TEAR-AWAY SHEATH INTRODUCER SET WITH INTEGRAL HEMOSTASIS VALVE by Thomas Medical Products, Inc. — Product Code DYB

K934901 is an FDA 510(k) premarket notification submitted by Thomas Medical Products, Inc. for the device "TEAR-AWAY SHEATH INTRODUCER SET WITH INTEGRAL HEMOSTASIS VALVE". The FDA issued a decision of Substantially Equivalent on January 21, 1994. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Thomas Medical Products, Inc. has at least 10 other 510(k) clearances on record.