Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3042953152

FEI Number

3042953152

Entity Name

Embolization Inc

City/State/Country

Boulder, CO, US

Establishment Address

5421 Western Ave, Boulder, CO 80301, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

Boulder iQ (Owner Number: 10094690)

Owner / Operator Contact Address

5421 Western Ave, Boulder, CO 80301, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K250276

PMA Number

N/A

All Registered Proprietary Names

Nitinol Enhanced Device (NED)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2025-12-16

Official Correspondent

Melissa Brookshier

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Boulder iQ

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 3042953152. Last updated year: 2026. Please use registration number 3042953152 when referencing this establishment in official correspondence.