NUVASCULAR INC.

FDA Device Registration & Listing · Irvine, CA, US · Registration 3030003849

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
3030003849
FEI Number
3030003849
Entity Name
NUVASCULAR INC.
City/State/Country
Irvine, CA, US
Establishment Address
141 Innovation Dr Ste 100, Irvine, CA 92617, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Nuvascular Inc. (Owner Number: 10091454)
Owner / Operator Contact Address
141 Innovation Drive, Suite 100, Irvine, CA 92617, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K250133
PMA Number
N/A

All Registered Proprietary Names

HARBOR Occlusion Device

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 2025-07-10

Official Correspondent

Meadow Wang

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Nuvascular 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 3030003849. Last updated year: 2026. Please use registration number 3030003849 when referencing this establishment in official correspondence.
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