Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1649395

FEI Number

3000718472

Entity Name

GALT MEDICAL CORP.

City/State/Country

GARLAND, TX, US

Establishment Address

2220 Merritt Dr, GARLAND, TX 75041, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

Theragenics Corporation (Owner Number: 1037598)

Owner / Operator Contact Address

5203 BRISTOL INDUSTRIAL WAY, --, Buford, GA 30518, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K000313

PMA Number

N/A

All Registered Proprietary Names

GUIDEWIRE INTRODUCER NEEDLE Valved Tearaway Introducer Dilator Coaxial Coaxial Syringe MicroSlide Tearaway Introducer CATHETER NEEDLE Nitinol Guidewires (Mandrel) Blade GaltStick Micro-Access Tearaway

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	Class 1	870.4500	2005-12-30
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2012-12-27
DRE	Dilator, Vessel, For Percutaneous Catheterization	Cardiovascular	Class 2	870.1310	2020-03-09
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2020-03-09
DTL	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4290	2015-12-28
DRE	Dilator, Vessel, For Percutaneous Catheterization	Cardiovascular	Class 2	870.1310	2017-11-01
DRE	Dilator, Vessel, For Percutaneous Catheterization	Cardiovascular	Class 2	870.1310	2007-11-20
GAX	Tourniquet, Nonpneumatic	General, Plastic Surgery	Class 1	878.5900	2024-01-22
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	2004-05-12
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2013-04-17
GCB	Needle, Catheter	General, Plastic Surgery	Class 1	878.4200	2012-12-27
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2014-12-11
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2007-11-20
GES	Blade, Scalpel	General, Plastic Surgery	Class 1	878.4800	2004-05-12
DRE	Dilator, Vessel, For Percutaneous Catheterization	Cardiovascular	Class 2	870.1310	2007-11-20
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2007-11-20

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Theragenics Corporation

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3036802499	Theragenics Costa Rica Limitada	El Coyol, Alajuela, CR
3011623145	Theragenics Costa Rica Limitada	El Coyol Alajuela, CR
1037598	THERAGENICS CORP.	BUFORD, GA, US
3006283319	NeedleTech Products, Inc.	N Attleboro, MA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
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
K233691	Acutus Medical, Inc.	FlexCath Cross Transseptal Solution	2023-12-17
K915078	North American Instrument Corp.	MORSE HEMOSTATIC CATHETER INTRODUCER SET	1992-06-10

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-04	Rultract Inc	1	Rultract Surgical Retractor, 4100 Series, all system configurations, reusable.
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.
Z-0030-2009	Boston Scientific Corporation	2	Platinum Plus" LT , REF 46-601, UPN M001466010, LT/0.018/180, Sterilized with ethylene oxide gas, Rx only, Legal Manufacturer Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01760-1537, Made in USA: 8600 NW 41st Street, Miami, FL 33166-6202. The Platinum Plus" Guidewire facilitates placement of a catheter during diagnostic or interventional intravascular procedures. The wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches.
Z-0031-2009	Boston Scientific Corporation	2	Platinum Plus" LT , REF 46-602, UPN M001466020, LT/0.018/260, Sterilized with ethylene oxide gas, Rx only, Legal Manufacturer Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01760-1537, Made in USA: 8600 NW 41st Street, Miami, FL 33166-6202. The Platinum Plus" Guidewire facilitates placement of a catheter during diagnostic or interventional intravascular procedures. The wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1649395. Last updated year: 2026. Please use registration number 1649395 when referencing this establishment in official correspondence.