Data / Medical devices / Mexico / Baxter S.A. De C.V.

Baxter S.A. De C.V.: FDA-registered device maker in Civac, Jiutepec, Morelos, Mexico, 6 510(k) clearances

Name: Baxter S.A. De C.V. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Baxter S.A. De C.V. is registered with the FDA (registration 8030639) in Civac, Jiutepec, Morelos, Mexico. It lists 6 device types. The FDA files 6 510(k) clearances under its listings, the newest dated January 6, 2017. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 8030639
FEI number: 6898
Address: Av. De Los 50 Metros No. 2, Civac, Jiutepec, Morelos, Mexico, 62578
Owner or operator: Vantive US Healthcare LLC (9038727)
Roles: Exporter to the US, Manufacturer
First device listed: March 21, 2007
Registered through: 2026
Brand names listed: GAMBRO CARTRIDGE BLOOD SETS, MiniCap with Povidone-Iodine Solution, POLYFLUX 140H, 170H, 210H, POLYFLUX 14L, 17L, 21L, PRISMASATE, PrismaSATE dialysis solutions, Revaclear

Devices it lists

Device	Product code	Class	Role	Source
Dialysate Concentrate For Hemodialysis (Liquid Or Powder)	KPO	2	Manufacturer	accessdata.fda.gov
Dialyzer, Capillary, Hollow Fiber	FJI	2	Exporter to the US	accessdata.fda.gov
Dialyzer, High Permeability With Or Without Sealed Dialysate System	KDI	2	Exporter to the US	accessdata.fda.gov
Hemodialyzer, Re-Use, High Flux	MSF	2	Exporter to the US	accessdata.fda.gov
Set, Administration, For Peritoneal Dialysis, Disposable	KDJ	2	Manufacturer	accessdata.fda.gov
Set, Tubing, Blood, With And Without Anti-Regurgitation Valve	FJK	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
January 6, 2017	K162887	PrismaSATE	KPO	Substantially Equivalent	Baxter Healthcare Corporation	accessdata.fda.gov
October 29, 2015	K152129	FlexiCap Disconnect Cap with Povidone-Iodine Solution, MiniCap with Povidone-Iodine Solution	KDJ	Substantially Equivalent	Baxter Healthcare Corporation	accessdata.fda.gov
May 2, 2013	K130039	REVACLEAR 300 DIALYZER, REVACLEAR 400 DIALYZER	KDI	Substantially Equivalent	Gambro Renal Products, Inc.	accessdata.fda.gov
February 4, 2008	K072908	PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUOUS RENAL REPLACEMENT THERAPY	KPO	Substantially Equivalent	Gambro Renal Products	accessdata.fda.gov
October 12, 2007	K070414	GAMBRO CARTRIDGE BLOOD SETS	FJK	Substantially Equivalent	Gambro Renal Products	accessdata.fda.gov
May 27, 2005	K043342	POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTIPLE USE, MODELS 14L, 17L, 21L, 140H, 170H, 210H,6LR, 8LR	FJI	Substantially Equivalent	Gambro Renal Products	accessdata.fda.gov

Compare with other makers

Updated January 6, 2017. 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.