Hemo-Cath Silicone Double Lumen Catheter

• • Terminated Z-1083-2015 FDA Class II ·initiated 21 Jan 2015

  Drug products contained within the kits may have been rendered ineffective by a duplicate sterilization process. The kits include one or more of the following drugs: 5ml ampule of lidocaine, 3ml Chloraprep one-step, 10ml pre-filled saline syringe, Hygea saline wipes, and 3ml tinted Chloraprep. No injuries or illnesses were reported.

510(k) Number

K890029 ↗

FDA Product Code

LFJ

Device Class

Class II

Regulation

21 CFR Part 876.5540

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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• Double Lumen Sublcavian-Femoral

  Class II

  FDA 510(k) K841530 Active Cleared 25 Jun 1984

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