Data / Medical devices / Colombia / Vygon Colombia S.A.

Vygon Colombia S.A.: FDA-registered device maker in BARRANQUILLA Atlantico, Colombia, 6 510(k) clearances

Name: Vygon Colombia S.A. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Vygon Colombia S.A. is registered with the FDA (registration 3004569180) in BARRANQUILLA Atlantico, Colombia. It lists 8 device types. The FDA files 6 510(k) clearances under its listings, the newest dated October 13, 2011. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3004569180
Address: Calle 79 No 75-342 L2, BARRANQUILLA Atlantico, Colombia, --
Owner or operator: VYGON S A (8020785)
Roles: Contract manufacturer, Contract sterilizer, Manufacturer
First device listed: November 21, 2006
Registered through: 2026
Brand names listed: 0000-9752-01, 246X2, 516.XX, 520.XX, 80.516.3XX, AMS-105-1, AMS-122-1, AMS-184-1 and more

Devices it lists

Device	Product code	Class	Role	Source
Brush, Scrub, Operating-Room	GEC	1	Manufacturer	accessdata.fda.gov
Catheters, Suction, Tracheobronchial	BSY	1	Contract manufacturer, Contract sterilizer, Manufacturer	accessdata.fda.gov
Filter, Infusion Line	FPB	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Gauze / Sponge,Nonresorbable For External Use	NAB	1	Manufacturer	accessdata.fda.gov
Set, Administration, Intravascular	FPA	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Tube, Feeding	FPD	2	Manufacturer	accessdata.fda.gov
Tube, Tracheal (W/Wo Connector)	BTR	2	Manufacturer	accessdata.fda.gov
Tubing, Fluid Delivery	FPK	2	Contract manufacturer	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
October 13, 2011	K100163	NUTRISAFE 2 FEEDING TUBES MODEL 362.XXX. 1362.XXX	FPD	Substantially Equivalent	Vygon Corp.	accessdata.fda.gov
May 22, 1996	K960795	VYGON DOUBLE LUMEN ENDOTRACHEAL TUBE	BTR	Substantially Equivalent	Vygon Corp.	accessdata.fda.gov
May 20, 1991	K910909	MUCAID	BSY	Substantially Equivalent	Vygon Corp.	accessdata.fda.gov
November 13, 1989	K894954	.22 & 1.2 MICRON IV FILTERS	FPB	Substantially Equivalent	Churchill Medical Systems, Inc.	accessdata.fda.gov
October 15, 1982	K822836	MICROFLEX-VENOFLUX	FPA	Substantially Equivalent	Exco, Inc.	accessdata.fda.gov
December 22, 1981	K813373	VYGON ENDOTRACHEAL TUBES	BTR	Substantially Equivalent	Exco, Inc.	accessdata.fda.gov

Compare with other makers

Updated October 13, 2011. 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.