Nipro Vascular Innovations Americas, Inc.

FDA Device Registration & Listing · SUNNYVALE, CA, US · Registration 3003524171

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
3003524171
FEI Number
3003524171
Entity Name
Nipro Vascular Innovations Americas, Inc.
City/State/Country
SUNNYVALE, CA, US
Establishment Address
870 Hermosa Dr, SUNNYVALE, CA 94085, US
Establishment Type(s)
Manufacture Device in the United States for Export Only
Owner / Operator
Nipro Vascular Innovations Americas, Inc. (Owner Number: 9042740)
Owner / Operator Contact Address
28 Crosby Drive, Suite 100, Bedford, MA 01730, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Captus ImpaxOmega Impax Versa

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MMX Device, Percutaneous Retrieval Cardiovascular Class 2 870.5150 2017-12-30
HCG Device, Neurovascular Embolization Neurology Class 2 882.5950 2015-11-17

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Nipro Vascular Innovations Americas, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3015551113 Nipro Vascular Innovations Americas, Inc. Bedford, MA, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K213494 ABBOTT MEDICAL Aveir Retrieval Catheter 2022-04-01
K951256 Target Therapeutics DETACHABLE PLATINUM COIL (GUGLIELMI DETACHABLE COIL, GDC) 1995-09-08

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003524171. Last updated year: 2026. Please use registration number 3003524171 when referencing this establishment in official correspondence.
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