Prolong, Models PL50, PL100, PL150

• • Terminated Z-1003-03 FDA Unclassified (pre-2012) ·initiated 9 May 2001

  Catheter does not fit through the needle resulting in delay of medical procedure

510(k) Number

K001129 ↗

FDA Product Code

CAZ

Models / Variants

PL50

PL100

PL150

Device Class

Class II

Regulation

21 CFR Part 868.5140

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

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  Class II

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  FDA 510(k) K822915 Active Cleared 28 Dec 1982

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  Class II

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  FDA 510(k) K822914 Active Cleared 3 Dec 1982

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  Class I

  FDA 510(k) K813552 Active Cleared 22 Feb 1982

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