HemoSonics, LLC (SC)

FDA Device Registration & Listing · Durham, NC, US · Registration 3014240198

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
3014240198
FEI Number
3014240198
Entity Name
HemoSonics, LLC (SC)
City/State/Country
Durham, NC, US
Establishment Address
4020 Stirrup Creek Drive, Suite 105, Durham, NC 27703, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
HemoSonics, LLC (Owner Number: 10057901)
Owner / Operator Contact Address
4020 Stirrup Creek Drive, Suite 105, Durham, NC 27703, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
DEN180017
PMA Number
N/A

All Registered Proprietary Names

QStat Cartridge Quantra Hemostasis Analyzer

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
QFR Coagulation System For The Measurement Of Whole Blood Viscoelastic Properties Hematology Class 2 864.5430 2023-11-06
QFR Coagulation System For The Measurement Of Whole Blood Viscoelastic Properties Hematology Class 2 864.5430 2019-04-15

Official Correspondent

Garrett Sparks

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

HemoSonics, LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014240198. Last updated year: 2026. Please use registration number 3014240198 when referencing this establishment in official correspondence.
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