Vantive US Healthcare LLC

FDA Device Registration & Listing · Deerfield, IL, US · Registration 3030306055

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
3030306055
FEI Number
3030306055
Entity Name
Vantive US Healthcare LLC
City/State/Country
Deerfield, IL, US
Establishment Address
One Baxter Parkway, Building 6, Deerfield, IL 60015, 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
Y
Expiration Date (Year)
2026
510(k) Number
K201867
PMA Number
N/A

All Registered Proprietary Names

Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the Homechoice Claria APD System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FKX System, Peritoneal, Automatic Delivery Gastroenterology, Urology Class 2 876.5630 2024-02-02

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
3006755813 Bieffe Medital Manufacturing Oued Ellil Tunisia Oued Ellil Manouba, TN
3033903155 Vantive Health GmbH Glattpark (Opfikon) Zurich, CH

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-0030-2020 Baxter Healthcare Corporation 2
L5C4531 X1 Integrated APD Set with Cassette 3-Prong Sterile, nonpyrogenic fluid path. Sterilized by ethylene oxide.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3030306055. Last updated year: 2026. Please use registration number 3030306055 when referencing this establishment in official correspondence.
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