Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1000533027

FEI Number

1000533027

Entity Name

NIPRO VASCULAR CORPORATION Fujigaoka Building

City/State/Country

Nagoya Aichi, JP

Establishment Address

108 Fujigaoka, Meito-ku, Nagoya Aichi 465-0032, JP

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

NIPRO VASCULAR CORPORATION (Owner Number: 10061300)

Owner / Operator Contact Address

5F KDX Nagoya Sakae Building, 4-5-3 Sakae, Naka-ku, Nagoya, JP-23 4600008, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

OKAYII Y-Connector Set GM-30 Inflation Device

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DTL	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4290	2019-10-07
PTM	Syringe, Balloon Inflation, Exempt	Cardiovascular	Class 2	870.1650	2021-02-12

Official Correspondent

Hirotaka Ishii

US Agent Details

Nozomi Yagi Email: RegulatoryNVIA@nipromed.com Phone: (781) 3459651

Related Public Records

Same Entity

NIPRO VASCULAR CORPORATION

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3030042169	NIPRO VASCULAR CORPORATION Aichi Facility	Seto Aichi, JP
3007835716	NIPRO VASCULAR CORPORATION	Nagoya Aichi, JP
3011826338	NIPRO VASCULAR CORPORATION Seto Facility / NIPRO VASCULAR CORPORATION Innovation Center	Seto Aichi, JP

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K915301	Advance Medical Designs, Inc.	ADVANCE STOPCOCK/HIGH PRESSURE STOPCOCK	1992-12-11

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1000533027. Last updated year: 2026. Please use registration number 1000533027 when referencing this establishment in official correspondence.