GAMBRO DIALYSATOREN GMBH

FDA Device Registration & Listing · HECHINGEN Baden-Wurttemberg, DE · Registration 9611369

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
9611369
FEI Number
3002807035
Entity Name
GAMBRO DIALYSATOREN GMBH
City/State/Country
HECHINGEN Baden-Wurttemberg, DE
Establishment Address
HOLGER - CRAFOORD - STRASSE 26, HECHINGEN Baden-Wurttemberg 72379, DE
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
N
Expiration Date (Year)
2026
510(k) Number
K043342
PMA Number
N/A

All Registered Proprietary Names

Revaclear 300 Revaclear 500 Revaclear 400 U9000 Ultrafilter AK 98 Dialysis Machine C-705 Accessory Expansion Chamber U9000 Plus Ultrafilter Revaclear POLYFLUX 140H, 170H, 210H POLYFLUX 14L, 17L, 21L

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System Gastroenterology, Urology Class 2 876.5860 2022-11-14
FIP Subsystem, Water Purification Gastroenterology, Urology Class 2 876.5665 2021-03-12
KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System Gastroenterology, Urology Class 2 876.5860 2021-03-12
FJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve Gastroenterology, Urology Class 2 876.5820 2021-03-12
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 2013-05-07
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

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
K110578 Mar Cor Purification, Inc. MILLENIUM HX PORTABLE REVERSE OSMOSIS WATER PURIFICATION SYSTEM 2011-05-20
K864831 Cobe Laboratories, Inc. COBE CENTRYSYSTEM 145E,160E,175E,190E DIALYZERS 1987-03-27

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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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9611369. Last updated year: 2026. Please use registration number 9611369 when referencing this establishment in official correspondence.
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