Data / Medical devices / Italy / Gambro Dasco S.P.A., Blood Line Division

Gambro Dasco S.P.A., Blood Line Division: FDA-registered device maker in MEDOLLA Modena, Italy, 5 510(k) clearances

Name: Gambro Dasco S.P.A., Blood Line Division FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Gambro Dasco S.P.A., Blood Line Division is registered with the FDA (registration 9610270) in MEDOLLA Modena, Italy. It lists 6 device types. The FDA files 5 510(k) clearances under its listings, the newest dated September 14, 2023. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 9610270
FEI number: 3012394756
Address: Via Modenese, 66, MEDOLLA Modena, Italy, 41036
Owner or operator: Vantive US Healthcare LLC (9038727)
Roles: Exporter to the US, Manufacturer, Specification developer
First device listed: August 31, 1999
Registered through: 2026
Brand names listed: AK 98 Dialysis Machine, Automated PD Set with Cassette 4-Prong, BICART, C-705 Accessory Expansion Chamber, CleanCart A, CleanCart C, AK 98 Dialysis Machine, HomeChoice PRO Automated Personal Cycler, Homechoice, Integrated APD Set with Cassette 3-prong and more

Devices it lists

Device	Product code	Class	Role	Source
Dialysate Concentrate For Hemodialysis (Liquid Or Powder)	KPO	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Dialyzer, High Permeability With Or Without Sealed Dialysate System	KDI	2	Manufacturer, Specification developer	accessdata.fda.gov
Set, Tubing, Blood, With And Without Anti-Regurgitation Valve	FJK	2	Specification developer	accessdata.fda.gov
Subsystem, Water Purification	FIP	2	Specification developer	accessdata.fda.gov
System, Hemodialysis, Remote Accessories	MON	1	Manufacturer	accessdata.fda.gov
System, Peritoneal, Automatic Delivery	FKX	2	Exporter to the US	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
September 14, 2023	K232467	CleanCart A, CleanCart C, AK 98 Hemodialysis Machine	KDI	Substantially Equivalent	Baxter Healthcare Corporation	accessdata.fda.gov
March 10, 2021	K201809	AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory	KDI	Substantially Equivalent	Baxter Healthcare Corportation	accessdata.fda.gov
March 30, 2011	K102936	HOMECHOICE/HOMECHOICE PRO AUTOMATED PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM MODEL 5C4471, 5C8310, 5C4471R AND 5C8310R	FKX	Substantially Equivalent	Baxter Healthcare Corp	accessdata.fda.gov
February 4, 2008	K072908	PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUOUS RENAL REPLACEMENT THERAPY	KPO	Substantially Equivalent	Gambro Renal Products	accessdata.fda.gov
January 8, 2002	K013724	BICART	KPO	Substantially Equivalent	Gambro Renal Products	accessdata.fda.gov

Compare with other makers

Updated September 14, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.