Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2314912

FEI Number

2314912

Entity Name

Vantive US Healthcare LLC

City/State/Country

MOUNTAIN HOME, AR, US

Establishment Address

1900 NORTH HIGHWAY 201, MOUNTAIN HOME, AR 72653, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Vantive US Healthcare LLC (Owner Number: 9038727)

Owner / Operator Contact Address

510 Lake Cook Road, Deerfield, IL 60015, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K923065

PMA Number

N/A

All Registered Proprietary Names

MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short MiniCap Extended Life PD Transfer Set with Twist Clamp Short Nose Clamp for Outlet Port of Plastic Container UltraClamp Tubing Clamp Minicap Extended Life PD Transfer Sets Locking Titanium Adapter for Peritoneal Dialysis Catheter and Locking Cap for Peritoneal Dialysis Catheter Adapter Effluent Sample Bag Automated Dialysis Cycler System Homechoice APD Set with Cassette 4 prong spike

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KDJ	Set, Administration, For Peritoneal Dialysis, Disposable	Gastroenterology, Urology	Class 2	876.5630	2024-10-23
FKK	Clamp, Line	Gastroenterology, Urology	Class 1	876.4730	1983-09-27
KDJ	Set, Administration, For Peritoneal Dialysis, Disposable	Gastroenterology, Urology	Class 2	876.5630	2024-10-23
FKX	System, Peritoneal, Automatic Delivery	Gastroenterology, Urology	Class 2	876.5630	2024-10-23

Official Correspondent

Jennifer Masek-Little

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Vantive US Healthcare LLC

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
9610725	Vantive Manufacturing Limited	CASTLEBAR, COUNTY MAYO Connaught, IE
9612168	Vantive Manufacturing Limited	SWINFORD Mayo, IE
8010182	GAMBRO INDUSTRIES	MEYZIEU CEDEX Rhone, FR
3030306055	Vantive US Healthcare LLC	Deerfield, IL, US
3006755813	Bieffe Medital Manufacturing Oued Ellil Tunisia	Oued Ellil Manouba, TN

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K822361	Travenol Laboratories, S.A.	DIANEAL SOLUTION EXCHANGE DEVICE #5C4193	1982-08-16
K933687	R & D Batteries, Inc.	R & D BATTERIES,INC. PART NUMBERS 5164, 5272, 5260	1994-02-09

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0017-05	Fresenius Medical Care North America	2	Fresenius Peritoneal Dialysis Premier Luer Lock Transfer Set 8'', Sterile with Female Safe Lock Connector Luer Lock and Slide Clamp Catalog Number: 050-30034
Z-0030-2020	Baxter Healthcare Corporation	2	L5C4531 X1 Integrated APD Set with Cassette 3-Prong Sterile, nonpyrogenic fluid path. Sterilized by ethylene oxide.

Similar Registrations

Registration Number	Establishment Name	Location
3038277270	BYONYKS MEDICAL DEVICES INC	Itasca, IL, US
1058584	Sterigenics US LLC	Charlotte, NC, US
3003504604	Gambro UF Solutions LLC	Plymouth, MN, US
3015335038	ERIKA DE REYNOSA, S.A. DE C.V.	CD, REYNOSA Tamaulipas, MX
3004111573	Sterigenics US LLC	Grand Prairie, TX, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2314912. Last updated year: 2026. Please use registration number 2314912 when referencing this establishment in official correspondence.