Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

TRINITY SLEEVE(S)

K-Number: K954489 · 1996-02-22

ApplicantDelphi Consulting Group
Decision Date1996-02-22
Product CodeJOW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TRINITY SLEEVE(S) is the device name listed in this FDA 510(k) record. The listed applicant is Delphi Consulting Group. It received FDA 510(k) clearance on 1996-02-22 under 510(k) number K954489. The device is classified under product code JOW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRINITY SLEEVE(S)?

TRINITY SLEEVE(S) is a medical device that received FDA 510(k) clearance on 1996-02-22. The listed applicant is Delphi Consulting Group. The 510(k) number is K954489.

When did TRINITY SLEEVE(S) receive FDA 510(k) clearance?

TRINITY SLEEVE(S) received FDA 510(k) clearance on 1996-02-22, under 510(k) number K954489.

Who is the listed applicant for TRINITY SLEEVE(S)?

The FDA 510(k) record lists Delphi Consulting Group as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRINITY SLEEVE(S)?

The FDA product code for TRINITY SLEEVE(S) is JOW.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Delphi Consulting Group as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K983680TRINITY II SINGLE CHAMBER DVT PUMPK963957TRINITY DVT SYSTEMK970014TRINITY SLEEVES, HUNTLEIGH PUMP COMPATIBLE(T.B.D.)K961937SIMULSCOPE AUSCULTATION AND SIMULSCOPE BEDSIDE AUSCULTATION SYSTEMK961301E-SCOPE ELECTRONIC STETHOSCOPE MODEL 718-7120

Related Devices (Code: JOW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261807Sequential Circulator (SC-4004-DL, SC-4008-DL)Bio Compression Systems, Inc.K254217AerloomEvolym, LLCK253555Flexitouch® Plus Advanced Pneumatic Compression SystemTactile MedicalK253386DVT GarmentVistar Medical Supplies Co., Ltd.K250242Compression Therapy Device (LGT-2202DVT)Guangzhou Longest Medical Technology Co., Ltd.K254267NanoPress 760A-BT (760A-BT)Mego Afek , Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑