Transseptal Needle/Trocar

• • Terminated Z-1375-2016 FDA Class II ·initiated 15 Mar 2016

  Merit Medical Systems, Inc. is voluntarily conducting a recall of one lot of the TSX" Transseptal Needle due to a discrepancy between the labeling and the actual configuration of the device in the packaging. The curve dimensional values on the labels of this lot incorrectly indicate a 50 curve, rather than the correct 86 curve

510(k) Number

K011727 ↗

FDA Product Code

DRC

Device Class

Class II

Regulation

21 CFR Part 870.1390

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Multi-Port Y Introducer Set

  Class II

  FDA 510(k) K931587 Active Cleared 6 Oct 1993

• Reinforced Catheter Introducer System (Rcis)

  Class II

  FDA 510(k) K081341 Active Cleared 14 May 2008

• Coronary Sinus Guide and Lateral Vein Introducer Kits Open recall

  Class II

  FDA 510(k) K120158 Active Cleared 14 Aug 2012

• Long Length Percutaneous Introducer Set

  Class II

  FDA 510(k) K924456 Active Cleared 22 Mar 1993

• Hemodialysis Introducer Set

  Class II

  FDA 510(k) K961780 Active Cleared 24 Dec 1996

• Tear-Away Sheath Introducer Set with Integral Hemostasis Valve

  Class II

  FDA 510(k) K934901 Active Cleared 21 Jan 1994

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