HighLife Medical

FDA Device Registration & Listing · Irvine, CA, US · Registration 3010410494

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
3010410494
FEI Number
3010410494
Entity Name
HighLife Medical
City/State/Country
Irvine, CA, US
Establishment Address
12 Goodyear Ste 125, Irvine, CA 92618, US
Establishment Type(s)
Manufacture Device in the United States for Export Only
Owner / Operator
HighLife Medical (Owner Number: 10050888)
Owner / Operator Contact Address
12 Goodyear, Suite 125, Irvine, CA 92618, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Valve Loading Tool Loop Placement Catheter SAI Delivery Catheter Sub-Annular Implant Trans-Septal Delivery Catheter 28mm Mitral Heart Valve, LAV 28mm Mitral Heart Valve

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DYE Replacement Heart-Valve Cardiovascular Class 3 870.3925 2016-01-13

Official Correspondent

Eric Simon

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

HighLife 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 3010410494. Last updated year: 2026. Please use registration number 3010410494 when referencing this establishment in official correspondence.
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