Portex Epidural Catheter

• • Terminated Z-2050-2009 FDA Unclassified (pre-2012) ·initiated 15 Jul 2009

  Portex Continuous Epidural Tray was distributed with a 20G closed end, three eyed, nylon catheter without a stylet instead of the 20 G open end Teflon catheter with stylet specified on the label.

510(k) Number

K062005 ↗

FDA Product Code

BSO

Device Class

Class II

Regulation

21 CFR Part 868.5120

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

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