Modification to: Bd Durasafe Plus Epidural Lock Cse Needle Set/Kit

• • Terminated Z-0725-2018 FDA Class II ·initiated 12 Sep 2017 ·on shared 510(k) K012584

  The tucking depth feature of this catheter introducer is marginally outside the upper specification.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K012584 ↗

FDA Product Code

CAZ

Device Class

Class II

Regulation

21 CFR Part 868.5140

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• BD Surgiphor Antimicrobial Irrigation System

  Class II

  FDA 510(k) K221504 Active Cleared 14 Oct 2022

• 0.9% Sodium Chloride Injection, Usp Bd Pre-Filled Flush Syringe

  Class II

  FDA 510(k) K011982 Active Cleared 17 Jul 2001

• Bd Bifurcated Needle, Models 301754, 301755, 301756, 301757

  Class II

  FDA 510(k) K020523 Active Cleared 20 Mar 2002

• Bd Vacutainer Plus Plastic Urine C&S Preservayive Tubes and Kits

  Class I

  FDA 510(k) K024240 Active Cleared 26 Mar 2003

• Bd Pre-Filled Heparin Lock Flush in 0.9% Sodium Chloride Injection, Usp Syringe

  Class II

  FDA 510(k) K011967 Active Cleared 23 Jan 2002

• Interlink Threaded Lock Cannula

  Class II

  FDA 510(k) K011858 Active Cleared 19 Jun 2001

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