LINEUS MEDICAL

FDA Device Registration & Listing · Fayetteville, AR, US · Registration 3019511659

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3019511659
FEI Number
3019511659
Entity Name
LINEUS MEDICAL
City/State/Country
Fayetteville, AR, US
Establishment Address
179 North Church Avenue, Suite 202, Fayetteville, AR 72701, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198
Owner / Operator
Lineus Medical (Owner Number: 10082114)
Owner / Operator Contact Address
179 North Church Avenue, Suite 202, Fayetteville, AR 72701, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
DEN190043
PMA Number
N/A

All Registered Proprietary Names

SafeBreak Vascular SafeBreak Vascular SafeBreak Vascular SafeBreak Vascular

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
QOI Intravenous Catheter Force-Activated Separation Device. General Hospital Class 2 880.5220 2023-12-08
QOI Intravenous Catheter Force-Activated Separation Device. General Hospital Class 2 880.5220 2023-12-08
QOI Intravenous Catheter Force-Activated Separation Device. General Hospital Class 2 880.5220 2023-12-08
QOI Intravenous Catheter Force-Activated Separation Device. General Hospital Class 2 880.5220 2021-06-16

Official Correspondent

Vance Clement

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Lineus Medical
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3019511659. Last updated year: 2026. Please use registration number 3019511659 when referencing this establishment in official correspondence.
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