Power Port-a-Cath, Cath II, and P.A.S. Port T2 Power P.A.C. Implantable Venous Access Systems and Power Gripper Plus

• • Terminated Z-2499-2020 FDA Class II ·initiated 11 Jun 2020

  Smiths Medical became aware that one (1) lot of PORT-A-CATH II POWER P.A.C. Low Profile" System (SKU 21-4477-24) was packaged with an 8Fr catheter instead of a 6Fr catheter.

• • Terminated Z-0190-2020 FDA Class II ·initiated 8 Jul 2019

  Potential for certain GRIPPER Needles to contain an occluded or blocked needle.

510(k) Number

K072657 ↗

FDA Product Code

LJT

Device Class

Class II

Regulation

21 CFR Part 880.5965

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Deltec Cozmo Insulin Infusion Pump with Cozmonitor Blood Glucose Meter, Models 21-1815, 21-1816, 21-1817

  Class II

  FDA 510(k) K062323 Active Cleared 1 Nov 2006

• Smith Medical Peel-Away Sheath Introducers

  Class II

  FDA 510(k) K112407 Active Cleared 9 Feb 2012

• Port-A-Cath, Port-a-Cath II, Proport and P.A.S. Port Implantable Venous Access Systems with Dual Layer Catheter

  Class II

  FDA 510(k) K060036 Active Cleared 17 May 2006

• Cadd Administration Set with Flow Stop, Medication Cassette Reservoir with Flow Stop and Extension Set Open recall

  Class II

  FDA 510(k) K040636 Active Cleared 19 May 2004

• Gripper Micro Needle

  Class II

  FDA 510(k) K072059 Active Cleared 1 Nov 2007

• Cadd-Sentry Pro Medication Safety Software-Administrator (21-6275), Point of Care (21-6276)

  Class II

  FDA 510(k) K072955 Active Cleared 13 Feb 2008

See all devices from Smiths Medical MD, Inc. →