Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3038966633

FEI Number

3038966633

Entity Name

Abbott Medical Mexico, S. de R.L. de C.V.

City/State/Country

Santa Rosa Jauregui Queretaro, MX

Establishment Address

Avenida FINSA 156, Lote 12, Parque Industrial FINSA III, Santa Rosa Jauregui Queretaro C.P. 76223, MX

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ABBOTT LABORATORIES (Owner Number: 1415939)

Owner / Operator Contact Address

100 ABBOTT PARK RD., D-03Q3, AP52-1, Abbott Park, IL 60064, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K251211

PMA Number

N/A

All Registered Proprietary Names

ViewFlex Xtra ICE Catheter ViewFlex X ICE Catheter, Sensor Enabled Advisor HD Grid Sensor Enabled, High Density Mapping Catheter ViewFlex Eco, Reprocessed ICE Catheter Agilis NxT Steerable Introducer Dual Reach, Steerable Introducer Agilis NxT, Steerable Introducer Advisor HD Grid X, Sensor Enabled, High Density Mapping Catheter ViewFlex Xtra, ICE Catheter

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OBJ	Catheter, Ultrasound, Intravascular	Cardiovascular	Class 2	870.1200	2025-09-04
OBJ	Catheter, Ultrasound, Intravascular	Cardiovascular	Class 2	870.1200	2025-07-01
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2025-07-01
OWQ	Reprocessed Intravascular Ultrasound Catheter	Cardiovascular	Class 2	870.1200	2025-07-01
MTD	Catheter, Intracardiac Mapping, High-Density Array	Cardiovascular	Class 2	870.1220	2025-07-01

Official Correspondent

No official correspondent registered.

US Agent Details

Barb Scherber Email: Barb.Scherber@Abbott.com Phone: (651) 7567518

Related Public Records

Same Entity

ABBOTT LABORATORIES

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3004032053	Abbott S.r.l.	Milan Lombardy, IT
3011706799	Abbott Medical	Atlanta, GA, US
1628664	ABBOTT LABORATORIES	IRVING, TX, US
3023268435	Abbott Automation Solutions GmbH	Hamburg, DE
3001883144	St. Jude Medical Brasil Ltda.	Belo Horizonte Minas Gerais, BR

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K251211	ABBOTT MEDICAL	ViewFlex Xtra ICE Catheter; ViewFlex Eco Reprocessed ICE Catheter; Advisor HD Grid Mapping Catheter, Sensor Enabled; Advisor HD Grid X Mapping Catheter, Sensor Enabled; Agilis NxT Steerable Introducer; Agilis NxT Steerable Introducer Dual-Reach	2025-05-23
K251231	ABBOTT MEDICAL	ViewFlex X ICE Catheter, Sensor Enabled	2025-05-20
K101883	St Jude Medical	6F ENGAGE/ENGAGE TR INTRODUCER	2010-09-07
K034025	Nmt Medical, Inc.	NMT MEDICAL TRANSSEPTAL SHEATH SET, MODELS TSS-10-HSC, TSS-11-HSC, TSS12-HSC	2004-03-26
K122854	Arrow International (Subsidiary of Teleflex Inc.)	ARROW GLIDETHRU PEEL-AWAY SHEATH/DILATOR INTRODUCER	2013-01-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-2016	Biosense Webster, Inc.	2	SOUNDSTAR eco 8F and 10F Diagnostic Ultrasound Catheters. For intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart.
Z-0783-2020	Abbott Medical	2	Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303
Z-0789-2020	Abbott Medical	2	Fast-Cath Hemostasis Introducer, HEMOSTASIS INTRODUCER, 8.5F, 2.83 mm, REF 406143 - Product Usage: The Fast-Cath Hemostasis Introducers are indicated for the introduction of angiographic catheters, closed-end catheters, balloon catheters, and electrodes into a vessel where minimizing blood loss is essential.

Similar Registrations

Registration Number	Establishment Name	Location
3013844297	DANELIS MEDICAL LIMITED	Rhayader Powys, GB
1058584	Sterigenics US LLC	Charlotte, NC, US
3017894900	Philips Ultrasound LLC	Cambridge, MA, US
3015859709	Arrow International, LLC (subsidiary of Teleflex Incorporated)	Wyomissing, PA, US
3019216	Philips Ultrasound LLC	BOTHELL, WA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3038966633. Last updated year: 2026. Please use registration number 3038966633 when referencing this establishment in official correspondence.