Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010754844

FEI Number

3010754844

Entity Name

Delta Med SpA

City/State/Country

Sorbolo Levante di Brescello Reggio Emilia, IT

Establishment Address

Street Emilio Gino Segre 6, Sorbolo Levante di Brescello Reggio Emilia 42041, IT

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Delta Med SpA (Owner Number: 10056736)

Owner / Operator Contact Address

via Guido Rossa 20, viadana, IT-MN 46019, IT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K200373

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2020-09-14

Official Correspondent

Gabriele Giovanelli

US Agent Details

Stephen H. Lieberman Business: Donawa Lifescience INC Email: lieberman@donawa.com Phone: (1) 3020777

Related Public Records

Same Entity

Delta Med SpA

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3006846316	Delta Med SpA	viadana Mantova, IT

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K943349	Quinton, Inc.	MAHURKAR DUAL LUMEN CATHETER	1995-03-22
K912158	Medical Device Inspection Co., Inc.	CENTRAL VENOUS CATHETER DRESSING CHANGE TRAY	1991-10-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2024	ARROW INTERNATIONAL Inc.	2	Arrow ErgoPack Complete, Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC, REF CDC-42854- PCN1A; catheter, intravascular, therapeutic, long-term greater than 30 days
Z-0003-2024	ARROW INTERNATIONAL Inc.	2	Arrow Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC, REF CDC-45854-P1A; catheter, intravascular, therapeutic, long-term greater than 30 days
Z-0009-2023	B Braun Medical Inc	2	Introcan Safety FEP 14G, 2.2x32MM-US, Product Code 4251890-02. A passive anti-needle device to provide venous or arterial access.
Z-0025-2024	Becton Dickinson Infusion Therapy Systems Inc.	2	REF: 386862, BD Cathena Safety IV catheter with BD Multiguard Technology, 20 GA 1.00 IN, 1.1 x 25 mm 64 mL/min , Rx Only, Sterile EO

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3015859709	Arrow International, LLC (subsidiary of Teleflex Incorporated)	Wyomissing, PA, US
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010754844. Last updated year: 2026. Please use registration number 3010754844 when referencing this establishment in official correspondence.