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Galt Medical Corp.: FDA-registered device maker in Garland, TX, United States, 13 510(k) clearances

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

Galt Medical Corp. is registered with the FDA (registration 1649395) in Garland, TX, United States. It lists 12 device types. The FDA files 13 510(k) clearances under its listings, the newest dated September 26, 2019. 7 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this one Watch Galt Medical Corp.

FDA registration number: 1649395
FEI number: 3000718472
Address: 2220 Merritt Dr, Garland, TX, United States, 75041
Owner or operator: Theragenics Corporation (1037598)
Roles: Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler
First device listed: May 12, 2004
Registered through: 2026
Brand names listed: Blade, CATHETER NEEDLE, Centeze Drainage Catheter, Coaxial, Dilator, Elite HV, GUIDEWIRE INTRODUCER NEEDLE, Galt Medical Corp. Introducer Kits and more

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Catheter	KGZ	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	DTL	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Blade, Scalpel	GES	1	Repackager or relabeler	accessdata.fda.gov
Dilator, Vessel, For Percutaneous Catheterization	DRE	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Instruments, Surgical, Cardiovascular	DWS	1	Manufacturer	accessdata.fda.gov
Introducer, Catheter	DYB	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Needle, Catheter	GCB	1	Manufacturer	accessdata.fda.gov
Percutaneous Sheath Introducer Kit	OFL	2	Manufacturer	accessdata.fda.gov
Stylet, Catheter	DRB	2	Manufacturer	accessdata.fda.gov
Syringe, Irrigating (Non Dental)	KYZ	1	Repackager or relabeler	accessdata.fda.gov
Tourniquet, Nonpneumatic	GAX	1	Complaint file establishment	accessdata.fda.gov
Wire, Guide, Catheter	DQX	2	Contract manufacturer, Manufacturer	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
September 26, 2019	K192195	Sterile Dilator	DRE	Substantially Equivalent	Galt Medical Corp.	accessdata.fda.gov
May 30, 2019	K182660	GaltTWS	DRB	Substantially Equivalent	Galt Medical Corp.	accessdata.fda.gov
December 2, 2015	K152528	Attachable Cath Lab Hemostasis Valve	DTL	Substantially Equivalent	Galt Medical Corp.	accessdata.fda.gov
April 23, 2015	K143252	Galt Tork, 0.010 to 0.020 inches (yellow), Galt Tork, 0.025 to 0.040 inches (orange)	DQX	Substantially Equivalent	Needle Tech Products, Inc.	accessdata.fda.gov
August 21, 2014	K140028	GALT VTI LOW INSERTION VALVE TEARAWAY INTRODUCER	DYB	Substantially Equivalent	Galt Medical Corp.	accessdata.fda.gov
April 12, 2013	K123430	MICROSLIDER TEARAWAY INTRODUCER SET	DYB	Substantially Equivalent	Galt Medical Corp.	accessdata.fda.gov
April 12, 2012	K112398	TRIV(TM) VALVED TEARAWAY INTRODUCER, TIRV(TM) VALVED TEARAWAY INTRODUCER WITH SIDE PORT	DYB	Substantially Equivalent	Galt Medical	accessdata.fda.gov
October 31, 2007	K071330	GALTSTICK INTRODUCER SYSTEM	DRE	Substantially Equivalent	Galt Medical Corp.	accessdata.fda.gov
February 9, 2005	K043525	CATHETER INTRODUCER	DYB	Substantially Equivalent	Galt Medical Corp.	accessdata.fda.gov
July 18, 2002	K021990	GALT MEDICAL GUIDEWIRE	DQX	Substantially Equivalent	Galt Medical Corp.	accessdata.fda.gov
August 1, 2000	K000737	COAXIAL DILATOR SET	DRE	Substantially Equivalent	Xentek Medical, Inc.	accessdata.fda.gov
June 16, 2000	K000313	TEARAWAY INTRODUCER SHEATH	DYB	Substantially Equivalent	Xentek Medical, Inc.	accessdata.fda.gov
February 1, 1999	K982559	GUIDEWIRE	DQX	Substantially Equivalent	Galt Medical Corp.	accessdata.fda.gov

Recalls

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

Initiated	Event	Class	Status	Product	Reason	Source
June 26, 2026	99369	Class II	Ongoing	Boston Scientific Enhance Transcarotid/Peripheral Access Kit REF: SR-4F21G7D-MP (Kit-075-03) Sheath with Dilator, Stiffen Dilator, Nitinol Mandrel Wire w/ Radiopaque Tip [Au}, Needle, Extension Tube with Stopcock	Black depth markings may detach from the outer sheath of the coaxial dilator introducer component of transcarotid-peripheral access kits.	accessdata.fda.gov
March 27, 2025	96622	Class II	Ongoing	GALT Centeze Catheter REF: DRC-002-05 DRC-002-06 The Centeze is intended for use in percutaneous fluid aspirations and small volume drainage procedures. For both adult and adolescent groups.	Due to a potential open seal in the sterile barrier packaging.	accessdata.fda.gov
May 8, 2023	92322	Class II	Ongoing	Tearaway Introducer Kit, REF: KIT-010-12, KIT-010-17, KIT-900-16	Sheath introducer assemblies could potentially, due to improper storage conditions, have a luer connection portion of the dilator hub that cracks or dislodges during use, which renders the dilator component unusable, and can require the use of a replacement device.	accessdata.fda.gov
November 16, 2020	86795	Class II	Terminated	Centeze Centesis Catheter, 6F, 10cm, 18Ga, 12cm, REF DRC-002-06 Centeze Centesis Catheter, 6F, 10cm, 18Ga, 12cm, REF DRC-006-16	Due to a manufacturing issue, the catheter tip geometry is incorrect (thicker wall) resulting in a more obtuse tip angle.	accessdata.fda.gov
May 2, 2018	80021	Class II	Terminated	1) ELITE HV, Hemostasis Valve Introducer System, Sterile EO, Rx Only, Catalog #: a) BCL-100-04; b) BCL-100-05; c) BCL-100-06; d) BCL-500-36; 2) Elite HV Introducer Set, Sterile EO, Rx Only, Catalog #: a) CLI-105-14; 3) A	The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced during a manufacturing step. Bacterial Endotoxins also called pyrogenic bacteria can activate the inflammatory process and produce fever, chills, and hypotension in a patient.	accessdata.fda.gov
July 25, 2014	68939	Class II	Terminated	GALT VALVED TEARAWAY INTRODUCER SET GALT VTI RX ONLY UNITS 7 STERILE EO Product Usage: Used in percutaneous procedures to introduce catheters and other intravascular devices into the peripheral vasculature.	The adhesive used in the product could dislodge when objects are inserted through the valve which could pose an embolic risk to the patient.	accessdata.fda.gov
February 8, 2010	54680	Not yet classified	Terminated	Micro Introducer Kit 5F, Model number: KIT-014-29, & Customer Model number: 7204. Vascular Solutions, 6464 Sycamore Court, Minneapolis, MN 53369.	Potential problem with pouch seal thus affecting sterile product.	accessdata.fda.gov

Compare with other makers

Updated August 7, 2026. 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.