CATHWORKS LTD.

FDA Device Registration & Listing · Kfar Saba Central, IL · Registration 3014129161

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3014129161
FEI Number
3014129161
Entity Name
CATHWORKS LTD.
City/State/Country
Kfar Saba Central, IL
Establishment Address
3 Rapaport, 4th floor, Kfar Saba Central 4465141, IL
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
N
Expiration Date (Year)
2026
510(k) Number
K182149
PMA Number
N/A

All Registered Proprietary Names

FFRangio™ FFRangio™ System

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
QEK Angiographic Coronary Vascular Physiologic Simulation Software Cardiovascular Class 2 870.1415 2026-05-19

Official Correspondent

No official correspondent registered.

US Agent Details

Tom Reichel Business: Medtronic Vascular Email: tom.j.reichel@medtronic.com Phone: (763) 5269693

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
3015192387 CATHWORKS Newport Beach, CA, US
3004185781 Medtronic, Inc. Tempe, AZ, US
3012520654 MEDTRONIC, INC. Billerica, MA, 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
3015192387 CATHWORKS Newport Beach, CA, US
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 3014129161. Last updated year: 2026. Please use registration number 3014129161 when referencing this establishment in official correspondence.
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