Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013320573

FEI Number

3013320573

Entity Name

TOKAI MEDICAL PRODUCTS

City/State/Country

Toki-City Gifu, JP

Establishment Address

210-3 Motogosho, Otomi, Izumi-cho, Toki-City Gifu 509-5132, JP

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Tokai Medical Products,Inc. (Owner Number: 10058070)

Owner / Operator Contact Address

1485 Sarayashiki, Taraga-cho, Kasugai-city, JP-23 486-0808, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

IABP7Fr

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DSP	System, Balloon, Intra-Aortic And Control	Cardiovascular	Class 2	870.3535	2018-07-03

Official Correspondent

Takashi Kumeno

US Agent Details

Sandie Hetland Business: Insightra Medical Inc Email: sandie@insightra.com Phone: (931) 8010576

Related Public Records

Same Entity

Tokai Medical Products,Inc.

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K903893	Datascope Corp.	DATASCOPE PERCOR STAT 9.5 FR 40CC INTRA-AORTIC BAL	1990-10-19

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013320573. Last updated year: 2026. Please use registration number 3013320573 when referencing this establishment in official correspondence.