Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012865735

FEI Number

3012865735

Entity Name

MARUHO RELUCENT, INC

City/State/Country

Santa Rosa, CA, US

Establishment Address

1415 N Dutton Ave Ste C, Santa Rosa, CA 95401, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Maruho Relucent, Inc (Owner Number: 10095291)

Owner / Operator Contact Address

1415 N Dutton Ave Ste C, Santa Rosa, CA 95401, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Neuroguard IEP® 3-in-1 Carotid Stent and Post-Dilatation Balloon System with Integrated Embolic Protection

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NIM	Stent, Carotid	Unknown	Class 3	N/A	2026-02-19

Official Correspondent

Kelsey Fox

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Maruho Relucent, Inc

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 3012865735. Last updated year: 2026. Please use registration number 3012865735 when referencing this establishment in official correspondence.