HTTPS://WWW.HJARTA.CARE

FDA Device Registration & Listing · Mequon, WI, US · Registration 3017785723

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
3017785723
FEI Number
3017785723
Entity Name
HTTPS://WWW.HJARTA.CARE
City/State/Country
Mequon, WI, US
Establishment Address
4617 W. Sleepy Hollow Lane, Mequon, WI 53092, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
https://www.hjarta.care (Owner Number: 10085118)
Owner / Operator Contact Address
4617 W. Sleepy Hollow Lane, Mequon, WI 53092, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
DEN250033
PMA Number
N/A

All Registered Proprietary Names

XplantR

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
SHR Device For Open Surgical Explant Of Endovascular Prostheses Cardiovascular Class 2 870.4520 2026-05-06

Official Correspondent

brian thorson

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

https://www.hjarta.care
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 3017785723. Last updated year: 2026. Please use registration number 3017785723 when referencing this establishment in official correspondence.
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