Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006846316

FEI Number

3006846316

Entity Name

Delta Med SpA

City/State/Country

viadana Mantova, IT

Establishment Address

via Guido Rossa 20, viadana Mantova 46019, IT

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Delta Med SpA (Owner Number: 10023539)

Owner / Operator Contact Address

Via Guido Rossa 20, Viadana, IT-MN 46019, IT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K171530

PMA Number

N/A

All Registered Proprietary Names

Delta Fly F20u Micro Bore Winged Safety Needles Delta Fly Safe 23G 30cm Delta Fly Micro Bore Winged Safety Needles Delta Fly Micro Bore Winged Safety Needle 21G 35cm Delta Fly Safe 21G 30cm Delta Fly Safe 25G 30cm Neo Delta Self Safe T 26G 19mm Neo Delta Self Safe 1 26G 19mm MERICATH SAFETY WINGED 24G 19MM Neo delta self safe 1 Neo delta self safe T Arrow International, Inc 312 Commerce Place Asheboro, NC 27203 Deltaven Closed I.V. Catheter Systems

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2014-11-28
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2013-02-15
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2014-04-04
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2018-01-09

Official Correspondent

No official correspondent registered.

US Agent Details

Stephen Lieberman Business: Donawa Lifescience INC Email: lieberman@donawa.com Phone: (561) 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
3010754844	Delta Med SpA	Sorbolo Levante di Brescello Reggio Emilia, IT

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K221518	Np Medical	NP Medical nCompass Extension Set with Stabilizing Base	2022-11-03
K953474	Medikmark, Inc.	IV START KIT	1995-10-02
K972493	Nipro Medical Corp.	NIPRO DISPOSABLE SOLUTION INFUSION SET	1997-09-18
K982672	Baxter Healthcare Corp	COLLEAGUE PUMP SYRINGE ADAPTER SET	1998-09-04
K143446	Roche Diagnostics GmbH	Accu-Chek FlexLink Plus infusion set	2015-08-13

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0010-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24
Z-0011-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24
Z-0012-2013	Baxter Healthcare Corp. Rt.	2	Baxter Interlink System Buretrol Solution Set with 150 mL Burette (Ball-Valve Drip Chamber); a sterile Rx IV fluid pathway device. Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.
Z-0012-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24
Z-0013-2013	Baxter Healthcare Corp. Rt.	2	Baxter Interlink System Buretrol Solution Set, 117" (3.0 m), with 150 mL Burette (Ball-Valve Drip Chamber) (Non-DEHP); a sterile Rx IV fluid pathway device; Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.

Similar Registrations

Registration Number	Establishment Name	Location
3018229072	INNOVATIVE HEALTH SCIENCES	Chester, NY, US
3030989877	INTERNATIONAL FILTER PRODUCTS DBA IFP MEDICAL	Sun Valley, CA, US
1047843	ISOMEDIX OPERATIONS INC.	SPARTANBURG, SC, US
3002807090	Sterigenics Germany GmbH	Wiesbaden Hesse, DE
3013319212	ICU MEDICAL, INC.	Lake Forest, IL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006846316. Last updated year: 2026. Please use registration number 3006846316 when referencing this establishment in official correspondence.