Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2245539

FEI Number

2245539

Entity Name

VLV ASSOCIATES, INC.

City/State/Country

Whippany, NJ, US

Establishment Address

34 Troy Rd, Whippany, NJ 07981, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

VLV ASSOCIATES, INC. (Owner Number: 2245539)

Owner / Operator Contact Address

34 Troy Road, --, Whippany, NJ 07981, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

STN Huber Safety Needle

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GAA	Needle, Aspiration And Injection, Disposable	General, Plastic Surgery	Class 1	878.4800	2007-06-28
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2020-01-06
EYK	Connector, Ureteral Catheter	Gastroenterology, Urology	Class 1	876.5130	2017-01-11
PTI	Non-Coring (Huber) Needle	General Hospital	Class 2	880.5570	2024-02-19
KGW	Ring (Wound Protector), Drape Retention, Internal	General, Plastic Surgery	Class 2	878.4370	2017-12-07

Official Correspondent

MICHAEL VAILLANCOURT

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

VLV ASSOCIATES, INC.

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
K781371	Ferris Mfg. Corp.	BONE MARROW ASPIRATION KIT	1978-09-20
K882805	Coopervision-Cilco	CILCO VILLASENOR PACHYMETER	1988-08-12
K791040	Shimadzu Corp.	SECTOR SCANNER, SDU-100, COMPUTERIZED	1979-10-04
K162372	Qt Ultrasound, LLC	QT Ultrasound Breast Scanner-1	2017-06-06
K930964	Acuson Corp.	ACUSON MODEL #29001 (DIAGNOSTIC ULTRASOUND DEVICE)	1994-10-26

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0017-2023	Hobbs Medical, Inc.	1	Hobbs Transbronchial Aspiration Needle and Vacu-lok Aspirating Syringe Catalog Number: 4620
Z-0018-2023	Hobbs Medical, Inc.	1	Hobbs Transbronchial Aspiration Needle Catalog Number: 4621
Z-0023-2011	Becton Dickinson & Company	1	BD 30G1/2 PrecisionGlide Needle;Catalog/Lot Number: 305106. Needles are intended for use in aspiration and injection of medications.
Z-0003-2011	Verathon, Inc.	2	BVI 9600 Bladder Volume Instrument, Aorta Scan Mode The BladderScan BVI 9600 with AortaScan Mode is a user-selectable, dual-function ultrasound device that projects ultrasound energy either into the lower abdomen to obtain an image of the bladder for measuring bladder volume, or into the mid-abdomen to obtain an image of the abdominal aorta for aortic diameter measurements.
Z-0004-2011	Verathon, Inc.	2	AortaScan AMI 9700 The AortaScan AMI 9700 is an ultrasound device that projects ultrasound energy into the mid-abdomen to obtain an image of the abdominal aorta for aortic diameter measurements

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2245539. Last updated year: 2026. Please use registration number 2245539 when referencing this establishment in official correspondence.