Data / Medical devices / United States / Merit Medical Systems, Inc.

Merit Medical Systems, Inc.: FDA-registered device maker in Houston, TX, United States, 1 510(k) clearance

Name: Merit Medical Systems, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Merit Medical Systems, Inc. is registered with the FDA (registration 3010665433) in Houston, TX, United States. It lists 15 device types. The FDA files 1 510(k) clearance under its listings, the newest dated October 4, 2000. 9 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this one Watch Merit Medical Systems, Inc.

FDA registration number: 3010665433
Address: 14646 Kirby Drive, Houston, TX, United States, 77047
Owner or operator: Merit Medical Systems, Inc. (1721504)
Roles: Contract manufacturer, Repackager or relabeler
First device listed: June 5, 2003
Registered through: 2027
Brand names listed: AEROmini Tracheobronchial Stent System, ARC Catheter, Advance Angiographic Needle, Aero DV Tracheobronchial Stent System, Aero Tracheo Stent and Delivery System, Aerosizer, Alimaxx E, CardiaGuide Fixed Curve Braided Transseptal Sheath and more

Devices it lists

Device	Product code	Class	Role	Source
Catheter, Continuous Flush	KRA	2	Contract manufacturer	accessdata.fda.gov
Catheter, Intravascular, Diagnostic	DQO	2	Contract manufacturer	accessdata.fda.gov
Catheter, Irrigation	GBX	1	Contract manufacturer	accessdata.fda.gov
Catheter, Percutaneous	DQY	2	Contract manufacturer	accessdata.fda.gov
Catheter, Peritoneal, Long-Term Indwelling	FJS	2	Contract manufacturer	accessdata.fda.gov
Catheter, Steerable	DRA	2	Contract manufacturer	accessdata.fda.gov
Device, Measuring, For Panendoscope	FDY	1	Contract manufacturer	accessdata.fda.gov
Dilator, Vessel, For Percutaneous Catheterization	DRE	2	Contract manufacturer	accessdata.fda.gov
Fluid Drainage Tray	PXU	1	Contract manufacturer	accessdata.fda.gov
Injector And Syringe, Angiographic	DXT	2	Contract manufacturer	accessdata.fda.gov
Introducer, Catheter	DYB	2	Contract manufacturer	accessdata.fda.gov
Prosthesis, Esophageal	ESW	2	Contract manufacturer	accessdata.fda.gov
Prosthesis, Tracheal, Expandable	JCT	2	Contract manufacturer	accessdata.fda.gov
Trocar	DRC	2	Contract manufacturer	accessdata.fda.gov
Wire, Guide, Catheter	DQX	2	Repackager or relabeler	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 4, 2000	K002289	INQWIRE DIAGNOSTIC GUIDE WIRE	DQX	Substantially Equivalent	Merit Medical Systems, Inc.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
October 7, 2011	60236	Not yet classified	Terminated	SafeSheath(R) CSG(R) Coronary Sinus guide Braided Core Hemostatic Introducer, SafeSheath(R) Worley Telescopic Braided Series, and Situs LDS2 Lead Delivery System - Catalog numbers: CSG/WORLEY/BCor-1-09; CSG/WORLEY/BCor-2	Radiopaque (RO)/soft tip of the braided core component in the CSG kits may detach from the braided core tube.	accessdata.fda.gov
December 16, 2010	57679	Not yet classified	Terminated	Thomas Medical Products, Y-Glide (Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass) for use during vascular interventional procedures. Part No. FTB-021-00, Catalog No. FTB-021-00.	Compromised sterility/weak or open seals.	accessdata.fda.gov
February 1, 2010	54525	Not yet classified	Terminated	Transseptal Sheath Introducer Kits (under trade names: HeartSpan, Channel FX, Torflex, Braided Guiding Introducer Kit). The product is shipped 5 per carton. Intended to allow left heart catheterization procedure to occur	Radiopaque tip may fracture	accessdata.fda.gov
December 17, 2009	54193	Not yet classified	Terminated	Thomas Medical Products Safesheath CSG (Coronary Sinus Guide) Hemostatic Tear away Introducer System with Infusion Side Port, for the introduction of various types of pacing or defibrillator leads and catheters. The prod	Radiopaque sheath tip may fracture	accessdata.fda.gov
October 21, 2009	53672	Not yet classified	Terminated	Reinforced Catheter Introducer System, 5 per carton. The product is sold under the Cordis Crossover and Cardiovascular Systems Inc (CSI) ViperSheath labels.	Sheath may break or fracture which may cause vessel damage or require surgical intervention to retrieve catheter pieces.	accessdata.fda.gov
September 12, 2008	49531	Not yet classified	Terminated	18 gage XTW needles, sold as a component in SafeSheath Hemostatic Tear-away Introducer System with Infusion Side Port kits or sold Bulk Non Sterile (BNS).	Difficulty inserting guidewire through introducer needle. Needle hub is not tapered down to the needle cannula.	accessdata.fda.gov
November 7, 2005	34028	Not yet classified	Terminated	Bard electrophysiology SSV H. Lee 9.5F split sheath with valve and sideport. The product is packaged in individual pouches and shipped 5 pouches per case.	mislabeled as 9.5F actually contains 10.5F	accessdata.fda.gov
October 14, 2004	30242	Not yet classified	Terminated	SafeSheath KR under the Pressure Products label. Tearaway KR Kit. Catalog number HLS/KR-1007. The product is shipped in cartons containing 5 units	Sheaths may fracture if exposed to excess fluorescent light	accessdata.fda.gov
June 11, 2004	29395	Not yet classified	Terminated	Safe Sheath CSG (Coronary Sinus Guide)-90.09; CSG (Coronary Sinus Guide)/BCor-90/09. These sheaths packaged in 5 individual boxed kits per case carton.	Degradation of sheath due to excessive exposure to (ultra violet) fluorescent light.	accessdata.fda.gov

Compare with other makers

Updated January 11, 2012. 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.