Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014443747

FEI Number

3014443747

Entity Name

EXIMO MEDICAL LTD

City/State/Country

Rehovot Central, IL

Establishment Address

Pekeris St. 3, Rehovot Central 7670203, IL

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

AngioDynamics (Owner Number: 10058638)

Owner / Operator Contact Address

26 Forest St., Marlborough, MA 01752, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K230709

PMA Number

N/A

All Registered Proprietary Names

Auryon Atherectomy System Auryon Atherectomy System AURYON ATHERECTOMY CATHETER 1.7 MM OTW AURYON ATHERECTOMY CATHETER 1.7 MM OTW - Hydrophilic Coated B-Laser(TM) Atherectomy System Auryon Atherectomy System Auryon Atherectomy System Auryon Atherectomy Catheter 0.9mm Longer Length (XL) OTW - Hydrophilic Coating Auryon Atherectomy Catheter 2.35mm - Hydrophilic Coated Auryon Atherectomy Catheter 0.9mm - Hydrophilic Coated Auryon Atherectomy Catheter 1.5mm - Hydrophilic Coated AURYON ATHERECTOMY CATHETER 1.5 MM OTW Auryon Atherectomy Catheter 2mm - Hydrophilic Coated AURYON ATHERECTOMY CATHETER 2.35 MM OTW Auryon Atherectomy Catheter 1.5mm Longer Length (XL) OTW - Hydrophilic Coating AURYON ATHERECTOMY CATHETER 2 MM OTW Auryon Atherectomy Catheter 0.9mm Longer Length (XL) OTW AURYON ATHERECTOMY CATHETER 0.9 MM OTW AuryonLaser System - for Infra Inguinal Atherectomy Auryon Atherectomy Catheter 1.5mm Longer Length (XL) OTW Auryon Atherectomy System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MCW	Catheter, Peripheral, Atherectomy	Cardiovascular	Class 2	870.4875	2020-12-08
MCW	Catheter, Peripheral, Atherectomy	Cardiovascular	Class 2	870.4875	2022-09-27
MCW	Catheter, Peripheral, Atherectomy	Cardiovascular	Class 2	870.4875	2024-07-24
MCW	Catheter, Peripheral, Atherectomy	Cardiovascular	Class 2	870.4875	2018-10-17
MCW	Catheter, Peripheral, Atherectomy	Cardiovascular	Class 2	870.4875	2026-04-13
MCW	Catheter, Peripheral, Atherectomy	Cardiovascular	Class 2	870.4875	2022-06-17
MCW	Catheter, Peripheral, Atherectomy	Cardiovascular	Class 2	870.4875	2023-12-19
MCW	Catheter, Peripheral, Atherectomy	Cardiovascular	Class 2	870.4875	2026-02-20

Official Correspondent

No official correspondent registered.

US Agent Details

Kasey Newcomb Business: AngioDynamics, Inc. Email: knewcomb@angiodynamics.com Phone: (860) 8179037

Related Public Records

Same Entity

AngioDynamics

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014443747. Last updated year: 2026. Please use registration number 3014443747 when referencing this establishment in official correspondence.