TRINITY SLEEVE(S)— 510(k) K954489

Substantially Equivalent

Delphi Consulting Group

FDA 510(k) clearance K954489 for TRINITY SLEEVE(S), Substantially Equivalent on 1996-02-22. Applicant: Delphi Consulting Group. Device class: 2.

Clearance details

Applicant: Delphi Consulting Group
Product code: Code JOW
Device class: Class 2
Regulation: 21 CFR 870.5800
Advisory panel: Cardiovascular
Date received: 1995-09-27
Decision date: 1996-02-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JOW

K261807 — Sequential Circulator (SC-4004-DL, SC-4008-DL)2026-09-11
K254217 — Aerloom2026-08-31
K253555 — Flexitouch® Plus Advanced Pneumatic Compression System2026-07-31
K253386 — DVT Garment2026-06-25
K250242 — Compression Therapy Device (LGT-2202DVT)2026-04-24

More clearances from Delphi Consulting Group

K983680 — TRINITY II SINGLE CHAMBER DVT PUMP1999-04-28
K963957 — TRINITY DVT SYSTEM1997-11-04
K970014 — TRINITY SLEEVES, HUNTLEIGH PUMP COMPATIBLE(T.B.D.)1997-08-06
K961937 — SIMULSCOPE AUSCULTATION AND SIMULSCOPE BEDSIDE AUSCULTATION SYSTEM1996-12-09
K961301 — E-SCOPE ELECTRONIC STETHOSCOPE MODEL 718-71201996-06-11

Data sourced from openFDA. This site is unofficial and independent of the FDA.