Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011826338

FEI Number

3011826338

Entity Name

NIPRO VASCULAR CORPORATION Seto Facility / NIPRO VASCULAR CORPORATION Innovation Center

City/State/Country

Seto Aichi, JP

Establishment Address

276-1 Idogane-cho, Seto Aichi 489-0976, JP

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

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 Aperta NSE PTA Balloon Dilatation Catheter 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
PNO	Catheter, Percutaneous, Cutting/Scoring	Cardiovascular	Class 2	870.1250	2025-05-07
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: (888) 6807339

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
1000533027	NIPRO VASCULAR CORPORATION Fujigaoka Building	Nagoya 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 3011826338. Last updated year: 2026. Please use registration number 3011826338 when referencing this establishment in official correspondence.