Trinity Sleeves, Huntleigh Pump Compatible(T.B.D.)

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K970014 ↗

FDA Product Code

JOW

Device Class

Class II

Regulation

21 CFR Part 870.5800

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Trinity Dvt System

  Class II

  FDA 510(k) K963957 Active Cleared 4 Nov 1997

• Trinity II Single Chamber Dvt Pump

  Class II

  FDA 510(k) K983680 Active Cleared 28 Apr 1999

• E-Scope Electronic Stethoscope Model 718-7120

  Class II

  FDA 510(k) K961301 Active Cleared 11 Jun 1996

• Trinity Sleeve(S)

  Class II

  FDA 510(k) K954489 Active Cleared 22 Feb 1996

• Simulscope Auscultation and Simulscope Bedside Auscultation System

  Class II

  FDA 510(k) K961937 Active Cleared 9 Dec 1996