LUTHER NEEDLESAFE PRODUCTS LLC

FDA Device Registration & Listing · Laguna Hills, CA, US · Registration 3017129766

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3017129766
FEI Number
3017129766
Entity Name
LUTHER NEEDLESAFE PRODUCTS LLC
City/State/Country
Laguna Hills, CA, US
Establishment Address
26052 Merit Cir Ste 107, Laguna Hills, CA 92653, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Luther Needlesafe Products LLC (Owner Number: 10087391)
Owner / Operator Contact Address
26052 Merit Circle, Suite 107, Laguna Hills, CA 92653, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K130518
PMA Number
N/A

All Registered Proprietary Names

Mini-Midline Extended Dwell Peripheral Catheter

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 2023-02-21

Official Correspondent

Amy Antonucci

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Luther Needlesafe Products LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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

Similar Registrations

Registration Number Establishment Name Location
2245270 VYGON USA Lansdale, PA, US
3016904853 SAINT JONES MANAGEMENT LP EOOD Sofia Sofia-Grad, BG
3013557562 CBR ENTERPRISE LIMITED Hong Kong, HK
3015859709 Arrow International, LLC (subsidiary of Teleflex Incorporated) Wyomissing, PA, US
1721676 Sterigenics U.S., LLC Salt Lake City, UT, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017129766. Last updated year: 2026. Please use registration number 3017129766 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.