Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010665433

FEI Number

3010665433

Entity Name

Merit Medical Systems, Inc.

City/State/Country

Houston, TX, US

Establishment Address

14646 Kirby Drive, Houston, TX 77047, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Merit Medical Systems, Inc. (Owner Number: 1721504)

Owner / Operator Contact Address

1600 West Merit Parkway, --, South Jordan, UT 84095, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

EndoMAXX SureCross Support Catheter Flex-Neck Infant Catheter InQwire Guidewire-Prelude Introducer HeartSpan Steerable Introducer Sheath Flex-Neck Extender/Repair Kit AEROmini Tracheobronchial Stent System ExxTended Catheter Alimaxx E Aero Tracheo Stent and Delivery System Aerosizer Aero DV Tracheobronchial Stent System Pericardiocentesis Catheter Kit Worley Impress Angiographic Catheter Flex-Neck Catheter ARC Catheter Advance Angiographic Needle Majestik Angiographic Needle Transseptal Needle,HeartSpan Transseptal Needle&Stylet Set,TSX Transseptal Needle,Transseptal Needle&Stylet Set;et al. Maestro Microcatheter ReSolve Non-Locking Drainage Catheter ReSolve Locking Drainage Catheter One-Step Centesis Catheter FastBreak Connector Cen-Step Centesis Catheter

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ESW	Prosthesis, Esophageal	General, Plastic Surgery	Class 2	878.3610	2011-09-02
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2013-04-05
FJS	Catheter, Peritoneal, Long-Term Indwelling	Gastroenterology, Urology	Class 2	876.5630	2012-12-21
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2007-12-07
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2013-11-21
FJS	Catheter, Peritoneal, Long-Term Indwelling	Gastroenterology, Urology	Class 2	876.5630	2012-12-21
JCT	Prosthesis, Tracheal, Expandable	General, Plastic Surgery	Class 2	878.3720	2018-09-26
FJS	Catheter, Peritoneal, Long-Term Indwelling	Gastroenterology, Urology	Class 2	876.5630	2012-12-21
ESW	Prosthesis, Esophageal	General, Plastic Surgery	Class 2	878.3610	2009-06-12
JCT	Prosthesis, Tracheal, Expandable	General, Plastic Surgery	Class 2	878.3720	2011-09-15
FDY	Device, Measuring, For Panendoscope	Gastroenterology, Urology	Class 1	876.1500	2009-06-11
JCT	Prosthesis, Tracheal, Expandable	General, Plastic Surgery	Class 2	878.3720	2009-06-10
PXU	Fluid Drainage Tray	General, Plastic Surgery	Class 1	878.4200	2020-11-20
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2007-12-07
FJS	Catheter, Peritoneal, Long-Term Indwelling	Gastroenterology, Urology	Class 2	876.5630	2012-12-21
FJS	Catheter, Peritoneal, Long-Term Indwelling	Gastroenterology, Urology	Class 2	876.5630	2012-12-21
DRC	Trocar	Cardiovascular	Class 2	870.1390	2007-12-07
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2017-09-05
GBX	Catheter, Irrigation	General, Plastic Surgery	Class 1	878.4200	2003-06-05

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Merit Medical Systems, Inc.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3021179744	VIEW POINT MEDICAL, INC.	Carlsbad, CA, US
3012276280	KA Medical	Arden Hills, MN, US
2032338	Merit Medical Systems, Inc.	ALISO VIEJO, CA, US
1125782	MERIT MEDICAL SYSTEMS, INC	Chester, VA, US
9615728	BIOSPHERE MEDICAL, S.A.	Roissy Val-d'Oise, FR

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K043580	Chestnut Medical Technologies, Inc.	ALLIGATOR RETRIEVAL DEVICE (ARD)	2005-03-24
K982883	Medtronics Interventional Vascular	MEDTRONIC 7F AND 8F ZUMA GUIDING CATHETER	1998-09-04
K132420	Reflow Medical	WINGMAN EXTENDABLE TIP SUPPORT CATHETER	2013-09-19
K082339	Endocross, Ltd.	ENABLER-P SUPPORT CATHETER	2008-11-20
K210009	CenterPoint Systems, LLC	Guiding Catheter	2021-11-24

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2017	Merit Medical Systems, Inc.	2	Merit Inflation Syringe Kit. Catalog Number KOS-02857
Z-0026-2020	Merit Medical Systems, Inc.	2	Custom Procedure Kit, Custom Kit, REF/Product Code: K12T-03688, single use, RX Only, Sterile EO, LATEX FREE, UDI: (01)00884450389409
Z-0027-2020	Merit Medical Systems, Inc.	2	Custom Procedure Kit, Vein Kit, Product Code/REF: K12T-10167, single use, RX Only, Sterile EO, UDI: (01) 00884450390580
Z-0001-2010	Penumbra Inc.	2	Penumbra Neuron Delivery Catheter 070, percutaneous catheter, catalog numbers PND6F0701058, PND6F070956, PND6F0701058M, and PND6F070956M; manufactured by Penumbra, Inc., Alameda, CA. Indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
Z-0003-2014	Cordis Corporation	2	Cordis ADROIT 6F Guiding Catheter Product Usage: For intravascular introduction of interventional and/or diagnostic devices into the coronary or peripheral vascular system.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010665433. Last updated year: 2026. Please use registration number 3010665433 when referencing this establishment in official correspondence.