Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9710284

FEI Number

3003084171

Entity Name

MEDINOL LTD.

City/State/Country

TEL-AVIV Tel Aviv, IL

Establishment Address

KIRYAT ATIDIM, BLDG. 8, TEL-AVIV Tel Aviv 6158101, IL

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

MEDINOL LTD. (Owner Number: 9031416)

Owner / Operator Contact Address

Kiryat Atidim, Bldg. 8, Tel Aviv, IL-TA 6158101, IL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K173581

PMA Number

N/A

All Registered Proprietary Names

NC Gallant PTCA Dilatation Catheter Gallant PTCA Dilatation Catheter

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LOX	Catheters, Transluminal Coronary Angioplasty, Percutaneous	Cardiovascular	Class 2	870.5100	2017-01-22
LOX	Catheters, Transluminal Coronary Angioplasty, Percutaneous	Cardiovascular	Class 2	870.5100	2018-06-24

Official Correspondent

No official correspondent registered.

US Agent Details

H. Semih Oktay Business: CardioMed Device Consultants, LLC Email: soktay@cardiomedllc.com Phone: (410) 6742060

Related Public Records

Same Entity

MEDINOL LTD.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3003084171	MEDINOL LTD.	Jerusalem, IL

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0030-04	N/A	2	Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 2cm Tip 20 mm Balloon, Catalog Number H74902071011
Z-0031-04	N/A	2	Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 2cm Tip 20 mm Balloon, Catalog Number H74902071051
Z-0032-04	N/A	2	Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 1 cm Tip and 20 mm Balloon, Catalog Number H74903628151

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9710284. Last updated year: 2026. Please use registration number 9710284 when referencing this establishment in official correspondence.