510(k) K022117

MAJESTIK (TM) SHIELDED ANGIOGRAPHY NEEDLE, MODEL STAN18T71W-25, MAJESTIK (TM) SHIELDED ANGIOGTAPHY NEEDLE, SRAN18T71WR-5 by Merit Medical Systems, Inc. — Product Code DRC

K022117 is an FDA 510(k) premarket notification submitted by Merit Medical Systems, Inc. for the device "MAJESTIK (TM) SHIELDED ANGIOGRAPHY NEEDLE, MODEL STAN18T71W-25, MAJESTIK (TM) SHIELDED ANGIOGTAPHY NEEDLE, SRAN18T71WR-5". The FDA issued a decision of Substantially Equivalent on October 11, 2002. The device falls under product code DRC (Trocar), a Class II device regulated under 21 CFR 870.1390. Merit Medical Systems, Inc. has at least 10 other 510(k) clearances on record.