Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3032828299

FEI Number

3032828299

Entity Name

VANTIVE HEALTHCARE TECHNOLOGIES PRIVATE LIMITED

City/State/Country

Bangalore Karnataka, IN

Establishment Address

Tower B, 16th Floor, Prestige Shantiniketan, Bangalore, Bangalore Karnataka 560048, IN

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

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

K961825

PMA Number

N/A

All Registered Proprietary Names

MARS Monitor ITC US, MARS Treatment Kit Type 1116/1 - X-MARS US, Prismaflex Control Unit CleanCart A, CleanCart C, AK 98 Dialysis Machine PrismaSATE dialysis solutions Minicap Extended Life PD Transfer Sets Locking Titanium Adapter for Peritoneal Dialysis Catheter and Locking Cap for Peritoneal Dialysis Catheter Adapter Sterile Bag Short Nose Clamp for Outlet Port of Plastic Container UltraClamp Tubing Clamp Amia Automated PD System with Sharesource Cycler Set PrisMax Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the Homechoice Claria APD System Ultra Set CAPD Disposable Y-Set 3L Ultra Set CAPD Disposable Y-Set

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
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	2023-09-15
KPO	Dialysate Concentrate For Hemodialysis (Liquid Or Powder)	Gastroenterology, Urology	Class 2	876.5820	2017-01-10
KDJ	Set, Administration, For Peritoneal Dialysis, Disposable	Gastroenterology, Urology	Class 2	876.5630	2024-10-23
MON	System, Hemodialysis, Remote Accessories	Gastroenterology, Urology	Class 1	876.5820	2013-09-25
FKK	Clamp, Line	Gastroenterology, Urology	Class 1	876.4730	1983-09-27
FKX	System, Peritoneal, Automatic Delivery	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	2017-06-05
FKX	System, Peritoneal, Automatic Delivery	Gastroenterology, Urology	Class 2	876.5630	2024-02-02
KDJ	Set, Administration, For Peritoneal Dialysis, Disposable	Gastroenterology, Urology	Class 2	876.5630	2024-10-23

Official Correspondent

Jennifer Masek-Little

US Agent Details

Jennifer Masek-Little Business: VANTIVE US HEALTHCARE LLC Email: jennifer.masek.little@vantive.com Phone: (815) 3548549

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
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
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-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
Z-0030-2024	Fresenius Medical Care Holdings, Inc.	2	2008T Hemodialysis System w/Bibag
Z-0031-2024	Fresenius Medical Care Holdings, Inc.	2	2008T GEN 2 Bibag without CDX

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3008822486	Delcath Systems, Inc.	Queensbury, NY, US
3038195011	Vantive US Healthcare LLC	Deerfield, IL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3032828299. Last updated year: 2026. Please use registration number 3032828299 when referencing this establishment in official correspondence.