Dual Lumen Catheter

• • Terminated Z-2226-2008 FDA Unclassified (pre-2012) ·initiated 25 Jun 2008

  Particulate matter in the catheter

510(k) Number

K043581 ↗

FDA Product Code

EYB

Device Class

Class II

Regulation

21 CFR Part 876.5130

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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See all devices from Acmi Corporation →