Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3038195011

FEI Number

3038195011

Entity Name

Vantive US Healthcare LLC

City/State/Country

Deerfield, IL, US

Establishment Address

510 Lake Cook Rd, Deerfield, IL 60015, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

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

K163530

PMA Number

N/A

All Registered Proprietary Names

Tipstop 12 ft Extension Set Empty Sterile Container 15L Cycler Drainage Bag PrisMax System Version 3 PRISMASATE Homechoice Integrated APD Set with Cassette 3-prong Automated PD Set with Cassette 4-Prong Low Recirculation Volume APD Set with Cassette HomeChoice PRO Automated Personal Cycler U9000 Plus Ultrafilter PRISMAFLEX HF 1000 SET PRISMAFLEX HF 1400 SET PrismaSATE dialysis solutions DIACLEAR MARS Monitor ITC US, MARS Treatment Kit Type 1116/1 - X-MARS US, Prismaflex Control Unit AK 98 Dialysis Machine POLYFLUX 140H, 170H, 210H POLYFLUX 14L, 17L, 21L PrisMax System Version 2 TherMax Short Nose Clamp for Outlet Port of Plastic Container UltraClamp Tubing Clamp Ultra Set CAPD Disposable Y-Set 3L Ultra Set CAPD Disposable Y-Set Revaclear PRISMAFLEX M150 SET Gambro Bloodlines Hospal Bloodlines Cycler Sets for Peritoneal Dialysis CARTRIDGE BLOOD SET Theranova Dialyzers (Theranova 400, Theranova 500) MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short MiniCap Extended Life PD Transfer Set with Twist Clamp CleanCart A, CleanCart C, AK 98 Dialysis Machine PrisMax

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2024-12-11
FKX	System, Peritoneal, Automatic Delivery	Gastroenterology, Urology	Class 2	876.5630	2024-10-23
KDJ	Set, Administration, For Peritoneal Dialysis, Disposable	Gastroenterology, Urology	Class 2	876.5630	2024-10-23
KDI	Dialyzer, High Permeability With Or Without Sealed Dialysate System	Gastroenterology, Urology	Class 2	876.5860	2020-09-15
KPO	Dialysate Concentrate For Hemodialysis (Liquid Or Powder)	Gastroenterology, Urology	Class 2	876.5820	2008-05-18
FKX	System, Peritoneal, Automatic Delivery	Gastroenterology, Urology	Class 2	876.5630	2020-04-01
FIP	Subsystem, Water Purification	Gastroenterology, Urology	Class 2	876.5665	2021-10-28
KDI	Dialyzer, High Permeability With Or Without Sealed Dialysate System	Gastroenterology, Urology	Class 2	876.5860	2008-05-18
KPO	Dialysate Concentrate For Hemodialysis (Liquid Or Powder)	Gastroenterology, Urology	Class 2	876.5820	2017-01-10
FIP	Subsystem, Water Purification	Gastroenterology, Urology	Class 2	876.5665	2010-02-16
FLD	Apparatus, Hemoperfusion, Sorbent	Gastroenterology, Urology	Class 2	876.5870	2014-06-18
KDI	Dialyzer, High Permeability With Or Without Sealed Dialysate System	Gastroenterology, Urology	Class 2	876.5860	2014-06-18
KDI	Dialyzer, High Permeability With Or Without Sealed Dialysate System	Gastroenterology, Urology	Class 2	876.5860	2025-08-06
MSF	Hemodialyzer, Re-Use, High Flux	Gastroenterology, Urology	Class 2	876.5860	2007-03-21
FJI	Dialyzer, Capillary, Hollow Fiber	Gastroenterology, Urology	Class 2	876.5820	2007-03-21
KDI	Dialyzer, High Permeability With Or Without Sealed Dialysate System	Gastroenterology, Urology	Class 2	876.5860	2007-03-21
KDI	Dialyzer, High Permeability With Or Without Sealed Dialysate System	Gastroenterology, Urology	Class 2	876.5860	2019-09-06
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
KDI	Dialyzer, High Permeability With Or Without Sealed Dialysate System	Gastroenterology, Urology	Class 2	876.5860	2013-05-07
KDI	Dialyzer, High Permeability With Or Without Sealed Dialysate System	Gastroenterology, Urology	Class 2	876.5860	2008-10-07
FJK	Set, Tubing, Blood, With And Without Anti-Regurgitation Valve	Gastroenterology, Urology	Class 2	876.5820	1998-04-14
KOC	Accessories, Blood Circuit, Hemodialysis	Gastroenterology, Urology	Class 2	876.5820	2006-11-22
KDJ	Set, Administration, For Peritoneal Dialysis, Disposable	Gastroenterology, Urology	Class 2	876.5630	2024-10-23
FJK	Set, Tubing, Blood, With And Without Anti-Regurgitation Valve	Gastroenterology, Urology	Class 2	876.5820	2010-11-04
QAX	Hemodialyzer With Expanded Solute Removal Profile	Gastroenterology, Urology	Class 2	876.5862	2020-08-31
KDJ	Set, Administration, For Peritoneal Dialysis, Disposable	Gastroenterology, Urology	Class 2	876.5630	2024-10-23
KDI	Dialyzer, High Permeability With Or Without Sealed Dialysate System	Gastroenterology, Urology	Class 2	876.5860	2023-09-15
KDI	Dialyzer, High Permeability With Or Without Sealed Dialysate System	Gastroenterology, Urology	Class 2	876.5860	2017-06-05

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
K811830	Cordis Corp.	C-DAK DUO-FLUX ARTIFICIAL KIDNEY	1981-09-21
K070320	Edwards Lifesciences Services GmbH	EDWARDS AQUARIUS HEMOFILTRATION SYSTEM, MODEL ABM 01	2007-06-07
K150880	Outset Medical	Tablo Console with Wireless Capability	2015-05-01

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.
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-0019-2025	Outset Medical, Inc.	2	Tablo Console, REF: PN-0003000, PN-0006000, part of the Tablo Hemodialysis System. The Tablo Hemodialysis System is indicated for use in patients with acute and/or chronic renal failure, with or without ultrafiltration, in an acute or chronic care facility.
Z-0028-2024	Fresenius Medical Care Holdings, Inc.	2	2008T Hemodialysis SYS, with CDX
Z-0029-2024	Fresenius Medical Care Holdings, Inc.	2	2008T Hemodialysis System without CDX

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3038195011. Last updated year: 2026. Please use registration number 3038195011 when referencing this establishment in official correspondence.