Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004569180

FEI Number

3004569180

Entity Name

VYGON COLOMBIA S.A.

City/State/Country

BARRANQUILLA Atlantico, CO

Establishment Address

CALLE 79 NO 75-342 L2, BARRANQUILLA Atlantico --, CO

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

VYGON S A (Owner Number: 8020785)

Owner / Operator Contact Address

5-11 RUE ADELINE, --, ECOUEN, FR-NOTA 95440, FR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K822836

PMA Number

N/A

All Registered Proprietary Names

Mucaid Vygon Double Lumen Endotracheal Tube IMPREGNATED SURGICAL BRUSH Filter Administration Sets Intravascular Extension Set AMS-899-G SSP-395 AMS-435CV-1 SS-761B AMS-391 AMS-635CV-1 516.XX 80.516.3XX 520.XX VYGON ENDOTRACHEAL TUBE Filter Set Intravascular Extension Set AMS-924C-1 AMS-467 AMS-467C 246X2 MICROFLEX

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BSY	Catheters, Suction, Tracheobronchial	Anesthesiology	Class 1	868.6810	2008-02-02
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2012-03-26
GEC	Brush, Scrub, Operating-Room	General, Plastic Surgery	Class 1	878.4800	2006-11-21
FPB	Filter, Infusion Line	General Hospital	Class 2	880.5440	2019-02-04
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2014-09-15
BTR	Tube, Tracheal (W/Wo Connector)	Anesthesiology	Class 2	868.5730	2006-11-21
FPB	Filter, Infusion Line	General Hospital	Class 2	880.5440	2020-06-17
FPK	Tubing, Fluid Delivery	General Hospital	Class 2	880.5440	2014-09-15
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2006-11-21

Official Correspondent

Chris Steinke

US Agent Details

Chris Steinke Business: Vygon USA Email: csteinke@vygon.com Phone: (603) 7435988

Related Public Records

Same Entity

VYGON S A

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3002808468	SAP	Saint Saulve Hauts-de-France, FR
3009291251	SIPV	Ecouen Ile-de-France, FR
3002808466	SIPA	Avesnes Sur Helpe Hauts-de-France, FR
3014663754	Vygon Portugal	Balter-Paredes Porto, PT
9612433	VYGON Germany GmbH	AACHEN North Rhine-Westphalia, DE

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K233341	Covidien, LLC	Shiley Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, 87440, 87445, 87450, 87455, 87460, 87465, 87470, 87475, 87480, 87485, 87490, 87495, 87410)	2024-05-20
K243785	Covidien, LLC	Shiley Oral/Nasal Tracheal Tube with TaperGuard Cuff Reinforced, Murphy Eye Shiley Tracheal Tube TaperGuard Cuff Reinforced with Stylet Shiley Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced Shiley Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced, Murphy Eye Shiley Oral/Nasal Tracheal Tube Cuffless Reinforced	2025-09-25
K221518	Np Medical	NP Medical nCompass Extension Set with Stabilizing Base	2022-11-03
K953474	Medikmark, Inc.	IV START KIT	1995-10-02
K972493	Nipro Medical Corp.	NIPRO DISPOSABLE SOLUTION INFUSION SET	1997-09-18

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0010-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24
Z-0011-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24
Z-0012-2013	Baxter Healthcare Corp. Rt.	2	Baxter Interlink System Buretrol Solution Set with 150 mL Burette (Ball-Valve Drip Chamber); a sterile Rx IV fluid pathway device. Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.
Z-0012-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24
Z-0013-2013	Baxter Healthcare Corp. Rt.	2	Baxter Interlink System Buretrol Solution Set, 117" (3.0 m), with 150 mL Burette (Ball-Valve Drip Chamber) (Non-DEHP); a sterile Rx IV fluid pathway device; Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.

Similar Registrations

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3011237770	Vygon Verneuil	Verneuil En Halatte Oise, FR
3016734145	CREATE BIOTECH CO., LTD.	Taoyuan City, TW

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004569180. Last updated year: 2026. Please use registration number 3004569180 when referencing this establishment in official correspondence.