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Galt Medical Corp.

United States·US-MF-000001777

Last updated September 17, 2026

Information

Country: United States
Address: 2220 Merritt Drive , Garland , United States
Website: galtmedical.com/
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 972-271-5177
PRRC Contact: David Derrick
EUDAMED SRN: US-MF-000001777
FDA FEI Number: 3000718472
DUNS Number: —

Catalogue (939)

Page 19 of 19

Device	Model / Reference	Registries	Class	Status
Elite HV® MB Introducer Kit	CLI-121-07	EUDAMEDFDA UDI	Class IIa	Active
Elite HV® T Introducer Kit	CLI-127-07	EUDAMEDFDA UDI	Class IIa	Active
GaltStick® Introducer Kit	KIT-036-06	EUDAMEDFDA UDI	Class IIa	Active
Elite HV® Introducer Kit	CLI-100-17	EUDAMEDFDA UDI	Class IIa	Active
Guidewire	SGW-038-05	EUDAMEDFDA UDI	Class IIa	Active
MicroSlide® Introducer Kit	KIT-051-02	EUDAMEDFDA UDI	Class IIa	Active
Guidewire	SGW-035-02	EUDAMEDFDA UDI	Class IIa	Active
Elite HV® R Introducer Kit	CLI-227-55	EUDAMEDFDA UDI	Class IIa	Active
Guidewire	SGW-015-03	EUDAMEDFDA UDI	Class IIa	Active
Galt VTI® Introducer Set	VTI-008-14	EUDAMEDFDA UDI	Class IIa	Active
Micro-Introducer Kit	KIT-039-02	EUDAMEDFDA UDI	Class IIa	Active
Galt VTI® Introducer Kit	KIT-077-14	EUDAMEDFDA UDI	Class IIa	Active
GaltStick® Introducer Set	INT-036-06	EUDAMEDFDA UDI	Class IIa	Active
Micro-Introducer Kit	KIT-011-03	EUDAMEDFDA UDI	Class IIa	Active
Elite HV® F Introducer Kit	CLI-115-16	EUDAMEDFDA UDI	Class IIa	Active
Micro-Introducer Kit	KIT-098-19	EUDAMEDFDA UDI	Class IIa	Active
Galt VTI® Introducer Set	VTI-008-07	EUDAMEDFDA UDI	Class IIa	Active
Elite HV® R Introducer Kit	CLI-230-07	EUDAMEDFDA UDI	Class IIa	Active
Galt VTI® Introducer Kit	KIT-077-12	EUDAMEDFDA UDI	Class IIa	Active
Tearaway Introducer Set	INT-107-70	EUDAMEDFDA UDI	Class IIa	Active
Elite HV® Introducer Kit	CLI-112-00	EUDAMEDFDA UDI	Class IIa	Active
Tearaway Introducer Set	INT-106-33	EUDAMEDFDA UDI	Class IIa	Active
Elite HV® T Introducer Kit	CLI-124-55	EUDAMEDFDA UDI	Class IIa	Active
Tearaway Introducer Set	INT-105-34	EUDAMEDFDA UDI	Class IIa	Active
Micro-Introducer Kit	KIT-011-20	EUDAMEDFDA UDI	Class IIa	Active
Galt VTI® Introducer Set	VTI-008-16	EUDAMEDFDA UDI	Class IIa	Active
Galt VTI® Introducer Kit	KIT-078-09	EUDAMEDFDA UDI	Class IIa	Active
Micro-Introducer Kit	KIT-033-04	EUDAMEDFDA UDI	Class IIa	Active
Micro-Introducer Kit	KIT-098-02	EUDAMEDFDA UDI	Class IIa	Active
Elite HV® R Introducer Kit	CLI-228-06	EUDAMEDFDA UDI	Class IIa	Active
Elite HV® F Introducer Kit	CLI-114-15	EUDAMEDFDA UDI	Class IIa	Active
Elite HV® F Introducer Kit	CLI-115-15	EUDAMEDFDA UDI	Class IIa	Active
Micro-Introducer Kit	KIT-039-05	EUDAMEDFDA UDI	Class IIa	Active
Elite HV® MB Introducer Kit	CLI-123-55	EUDAMEDFDA UDI	Class IIa	Active
Tearaway Introducer Kit	KIT-010-02	EUDAMEDFDA UDI	Class IIa	Active
Needle	NDL-100-17	EUDAMEDFDA UDI	Class IIa	Active
Guidewire	SGW-015-02	EUDAMEDFDA UDI	Class IIa	Active
Micro-Introducer Kit	KIT-098-04	EUDAMEDFDA UDI	Class IIa	Active
Elite HV® Introducer Kit	CLI-100-16	EUDAMEDFDA UDI	Class IIa	Active

Related Companies

Authorised Representatives

Emergo Europe B.V. NL

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (21)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Mar 27, 2025	Z-1731-2025	—	open, classified	Due to a potential open seal in the sterile barrier packaging .
Mar 27, 2025	Z-1733-2025	—	open, classified	Due to a potential open seal in the sterile barrier packaging .
Mar 27, 2025	Z-1736-2025	—	open, classified	Due to a potential open seal in the sterile barrier packaging.
Mar 27, 2025	Z-1735-2025	—	open, classified	Due to a potential open seal in the sterile barrier packaging.
Mar 27, 2025	Z-1732-2025	—	open, classified	Due to a potential open seal in the sterile barrier packaging .
Mar 27, 2025	Z-1734-2025	—	open, classified	Due to a potential open seal in the sterile barrier packaging.
Mar 27, 2025	Z-1737-2025	—	open, classified	Due to a potential open seal in the sterile barrier packaging.
May 8, 2023	Z-1969-2023	—	open, classified	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.
May 8, 2023	Z-1968-2023	—	open, classified	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.
Nov 16, 2020	Z-0568-2021	—	terminated	Due to a manufacturing issue, the catheter tip geometry is incorrect (thicker wall) resulting in a more obtuse tip angle.
May 2, 2018	Z-2565-2018	—	terminated	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.
May 2, 2018	Z-2563-2018	—	terminated	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.
May 2, 2018	Z-2562-2018	—	terminated	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.
May 2, 2018	Z-2558-2018	—	terminated	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.
May 2, 2018	Z-2560-2018	—	terminated	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.
May 2, 2018	Z-2564-2018	—	terminated	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.
May 2, 2018	Z-2561-2018	—	terminated	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.
May 2, 2018	Z-2559-2018	—	terminated	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.
Jul 25, 2014	Z-2589-2014	—	terminated	The adhesive used in the product could dislodge when objects are inserted through the valve which could pose an embolic risk to the patient.
Jul 25, 2014	Z-2588-2014	—	terminated	The adhesive used in the product could dislodge when objects are inserted through the valve which could pose an embolic risk to the patient.
Feb 8, 2010	Z-1592-2010	—	terminated	Potential problem with pouch seal thus affecting sterile product.