Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021009035

FEI Number

3021009035

Entity Name

Quasar Medical Tecate, S.A. de C.V

City/State/Country

Tecate Baja California, MX

Establishment Address

Calle los Olivos No. 6500, 1/D Modulo 3, Parque Industrial el Bajio, Tecate Baja California 21503, MX

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Quasar Medical Tecate, S.A. de C.V (Owner Number: 10094015)

Owner / Operator Contact Address

Calle De Los Olivos No. 6500, 1/D Modulo 3,, Parque Industrial el Bajio, Tecate, MX-BCN 21503, MX

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Liberant RX Large Bore Aspiration Tubing Riptide Large Bore Aspiriation Tubing and Riptide Collection Canister with Intermediate Tubing Gyrus ACMI-EZDILATE 3-Stage Balloon Dilatation Catheter Riptide Large Bore Aspiriation Tubing and Riptide Collection Canister with Intermediate Tubing LithoCrush V (MAJ-252)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BYY	Tube, Aspirating, Flexible, Connecting	General Hospital	Class 2	880.6740	2026-03-19
NRY	Catheter, Thrombus Retriever	Cardiovascular	Class 2	870.1250	2025-09-12
KNQ	Dilator, Esophageal	Gastroenterology, Urology	Class 2	876.5365	2025-09-12
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2025-09-12
NRY	Catheter, Thrombus Retriever	Cardiovascular	Class 2	870.1250	2025-09-12
LQC	Lithotriptor, Biliary Mechanical	Gastroenterology, Urology	Class 2	876.4500	2025-09-12

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Quasar Medical Tecate, S.A. de C.V

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K033736	Concentric Medical, Inc.	MERCI RETRIEVER, MODELS 90065, 90066	2004-08-11
K990935	Pilling Weck Surgical	JACKSON ESOPHAGEAL DILATOR	1999-05-17
K902734	Olympus Corp.	PR CANNULAS	1990-08-22

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-05	N/A	2	Biliary Stent System (6Fr 9mm x 30mm).
Z-0015-2011	Navilyst Medical, Inc	2	Exodus(TM) 8F (2.7 mm)/25 cm Standard Loop Multipurpose Drainage Catheter with Hydrophilic Coating, REF Catalog No. 10002, UPN Product No. H965100201, Rx ONLY, STERILE/EO --- Made in USA: 2301 Centennial Blvd., Jeffersonville, IN 47130 --- Manufactured for: Navilyst Medical, Inc. 26 Forest Street, Marlborough, MA 01752 USA --- Each box unit contains 5 catheters. --- The Exodus Standard Loop Multipurpose Drainage Catheter consists of a radiopaque polyurethane catheter with a locking pigtail distal end and is coated with a hydrophilic coating. Catheter markings are provided in centimeters on the shaft to indicate the distance form the distal tip. The catheter is provided with a trocar, a metal stiffening cannula and a plastic cannula. Multipurpose Drainage Catheters are intended for percutaneous drainage of fluid in the chest, abdomen and pelvis.
Z-0035-2009	Bard Peripheral Vascular Inc	2	Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX060201CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.
Z-0036-2009	Bard Peripheral Vascular Inc	2	Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX060203CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.
Z-0037-2009	Bard Peripheral Vascular Inc	2	Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX060301CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.

Similar Registrations

Registration Number	Establishment Name	Location
3030413693	Medway Supplies Inc	Lake Elsinore, CA, US
1062154	NDH MEDICAL, INC.	Saint Petersburg, FL, US
3010594263	JIANGSU WEIKANG JIEJING MEDICAL APPARATUS CO., LTD.	Shuyang Jiangsu, CN
3015967359	Stryker Instruments	Portage, MI, US
3003902679	ENTER MEDICAL CORPORATION	Chiayi County, TW

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3021009035. Last updated year: 2026. Please use registration number 3021009035 when referencing this establishment in official correspondence.