Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3030042169

FEI Number

3030042169

Entity Name

NIPRO VASCULAR CORPORATION Aichi Facility

City/State/Country

Seto Aichi, JP

Establishment Address

1-176 Shiokusagaoka, Seto Aichi 489-0899, JP

Establishment Type(s)

Manufacture Medical Device

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

K243944

PMA Number

N/A

All Registered Proprietary Names

Aperta NSE PTA Balloon Dilatation Catheter

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PNO	Catheter, Percutaneous, Cutting/Scoring	Cardiovascular	Class 2	870.1250	2025-05-07

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
3007835716	NIPRO VASCULAR CORPORATION	Nagoya Aichi, JP
3011826338	NIPRO VASCULAR CORPORATION Seto Facility / NIPRO VASCULAR CORPORATION Innovation Center	Seto Aichi, JP
1000533027	NIPRO VASCULAR CORPORATION Fujigaoka Building	Nagoya Aichi, JP

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3030042169. Last updated year: 2026. Please use registration number 3030042169 when referencing this establishment in official correspondence.