S4 MEDICAL CORP

FDA Device Registration & Listing · Chagrin Falls, OH, US · Registration 3019622578

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
3019622578
FEI Number
3019622578
Entity Name
S4 MEDICAL CORP
City/State/Country
Chagrin Falls, OH, US
Establishment Address
549 Washington St Ste 8, Chagrin Falls, OH 44022, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
S4 Medical Corp (Owner Number: 10082158)
Owner / Operator Contact Address
549 E Washington St, First Floor, Chagrin Falls, OH 44022, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
DEN230006
PMA Number
N/A

All Registered Proprietary Names

esolution

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
QXU Esophageal Protection Device For Use In Percutaneous Cardiac Catheter Ablation Procedures, Mechanical Deviation Cardiovascular Class 2 870.5710 2024-06-13

Official Correspondent

William Fuller

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

S4 Medical Corp
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 3019622578. Last updated year: 2026. Please use registration number 3019622578 when referencing this establishment in official correspondence.
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