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Delta Med SpA: FDA-registered device maker in viadana Mantova, Italy, 5 510(k) clearances

Name: Delta Med SpA FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Delta Med SpA is registered with the FDA (registration 3006846316) in viadana Mantova, Italy. It lists 4 device types. The FDA files 5 510(k) clearances under its listings, the newest dated August 26, 2020. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3006846316
Address: via Guido Rossa 20, viadana Mantova, Italy, 46019
Owner or operator: Delta Med SpA (10023539)
Roles: Contract manufacturer, Exporter to the US, Manufacturer
First device listed: November 30, 2007
Registered through: 2026
Brand names listed: Arrow International, Inc 312 Commerce Place Asheboro, NC 27203, Delta Fly F20u Micro Bore Winged Safety Needles, Delta Fly Micro Bore Winged Safety Needle 21G 35cm, Delta Fly Micro Bore Winged Safety Needles, Delta Fly Safe 21G 30cm, Delta Fly Safe 23G 30cm, Delta Fly Safe 25G 30cm, Deltaven Closed I.V. Catheter Systems and more

Devices it lists

Device	Product code	Class	Role	Source
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	FOZ	2	Exporter to the US, Manufacturer	accessdata.fda.gov
General Surgery Tray	LRO	2	Manufacturer	accessdata.fda.gov
Set, Administration, Intravascular	FPA	2	Manufacturer	accessdata.fda.gov
Syringe, Piston	FMF	2	Contract manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
August 26, 2020	K200373	Deltaven Fast Flash Closed I.V. Catheter Systems	FOZ	Substantially Equivalent	Delta Med Spa	accessdata.fda.gov
December 21, 2017	K171530	Deltaven XiV Max, Deltaven XiV Max FF	FOZ	Substantially Equivalent	Delta Med Spa	accessdata.fda.gov
August 5, 2014	K140175	INTRAVASCULAR ADMINISTRATION SET	FPA	Substantially Equivalent	Delta Med Spa	accessdata.fda.gov
December 28, 2012	K121007	NEO DELTA SELF SAFE T, NEO DELTA SELF SAFE T, NEO DELTA SELF SAFE 1, NEO DELTA SELF SAFE 1	FOZ	Substantially Equivalent	Delta Med Srl	accessdata.fda.gov
November 30, 2004	K041080	SURGICAL DRAPE KIT - D.I.R.R.A. SRL	LRO	Substantially Equivalent	D.I.R.R.A. S.R.L.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
June 21, 2021	88234	Class II	Ongoing	DELTAVEN Safety I.V. Catheter in Pur with closed system: a) REF 3836272 b) REF 3814272 c) REF 3845272 d) REF 3856272	Problems related to the sterilization of the medical devices; possible missing sterility of the medical device	accessdata.fda.gov

Compare with other makers

Updated August 26, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.