Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015192387

FEI Number

3015192387

Entity Name

CATHWORKS

City/State/Country

Newport Beach, CA, US

Establishment Address

4000 MacArthur Blvd, Suite 1025 - East Tower, Newport Beach, CA 92660, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Medtronic, Inc. (Owner Number: 2112641)

Owner / Operator Contact Address

710 Medtronic Parkway, Minneapolis, MN 55432, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K192442

PMA Number

N/A

All Registered Proprietary Names

FFRangio

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QEK	Angiographic Coronary Vascular Physiologic Simulation Software	Cardiovascular	Class 2	870.1415	2026-06-02

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Medtronic, 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
3007042319	HeartWare, Inc.	Miami Lakes, FL, US
3004497303	MEDTRONIC MEXICO EG	EMPALME Sonora, MX
3004185781	Medtronic, Inc.	Tempe, AZ, US
3012520654	MEDTRONIC, INC.	Billerica, MA, US
3004594267	Medtronic Care Management Services	Lafayette, CO, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K103464	Medtronic, Inc.	PACIFIC XTREME PTCA BALLOON DILATATION CATHETER	2010-12-22
K111339	Medtronic, Inc.	HEMOSTASIS MANAGMENT SYSTEM PLUS (HMS-PLUS)	2011-06-08

Similar Registrations

Registration Number	Establishment Name	Location
3014129161	CATHWORKS LTD.	Kfar Saba Central, IL
3004016520	SANMINA- SCI ISRAEL MEDICAL SYSTEMS LTD.	Maalot-Tarshiha Northern, IL
3028606342	OMAY(GUANGZHOU) MED TECHNOLOGIES CO., LTD	Guangzhou Guangdong, CN
3038274470	BRAINMATTERZ, INC	McKinney, TX, US
3012404174	LABORATORIO CHIMICO FARMACEUTICO A. SELLA SRL.	Schio Vicenza, IT

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015192387. Last updated year: 2026. Please use registration number 3015192387 when referencing this establishment in official correspondence.