Pleur-Evac Sahara Adult/Pediatric Chest Drainage System Model S-1100, S-1200, 2-2100, and S-2200 with Model S-100 Autotr

• • Terminated Z-1404-2015 FDA Class II ·initiated 13 Mar 2015

  Package contains incorrect sized unit: The adult sized S-1100-08LF product contains an infant sized chest drainage system.

510(k) Number

K962856 ↗

FDA Product Code

KDQ

Models / Variants

S-1100

S-1200

2-2100

S-2200 With Model S-100 Autotr

Device Class

Class II

Regulation

21 CFR Part 880.6740

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Pleur-Evac Chest Drainage Systems

  Class II

  FDA 510(k) K905768 Active Cleared 11 Feb 1991

• Deknatel Trocar Catheter

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  FDA 510(k) K873525 Active Cleared 2 Nov 1987

• Pleur-Evac(R) Adult/Pedi Dual Coll Chest Drain Sys

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• Pleur-Evac Cardiotomy Reservoir # Cr-9400 & 9400F

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  FDA 510(k) K926338 Active Cleared 26 Jul 1994

• Pleur-Evac-A-7000--Adult/Pedi Chest Drainage Syst

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  FDA 510(k) K882223 Active Cleared 16 Aug 1988

• Deknatel Temporary Cardiac Pacing Wire

  Class II

  FDA 510(k) K873728 Active Cleared 3 Nov 1987

See all devices from Deknatel, Inc. →