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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 11, 2002
Date Received
July 1, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Trocar
Device Class
Class II
Regulation Number
870.1390
Review Panel
CV
Submission Type