Pleur-Evac Shara Plus Model S-2150/Continuous Reinfusion Autotransfusion System(S-100)

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K963098 ↗

FDA Product Code

CAC

Device Class

Class II

Regulation

21 CFR Part 868.5830

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Pleur-Evac Chest Drainage Systems

  Class II

  FDA 510(k) K905768 Active Cleared 11 Feb 1991

• Deknatel Trocar Catheter

  Class II

  FDA 510(k) K873525 Active Cleared 2 Nov 1987

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

  Class II

  FDA 510(k) K924337 Active Cleared 28 Jul 1993

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

  Class II

  FDA 510(k) K926338 Active Cleared 26 Jul 1994

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

  Class II

  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. →