Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011623145

FEI Number

3011623145

Entity Name

Theragenics Costa Rica Limitada

City/State/Country

El Coyol Alajuela, CR

Establishment Address

Zona Franca El Coyol, Building B 13.3, El Coyol Alajuela 20113, CR

Establishment Type(s)

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

K192195

PMA Number

N/A

All Registered Proprietary Names

MicroSlide Tearaway Introducer Coaxial Coaxial Medcomp® BREEZE® AND BREEZE® XS INTRODUCER KIT Galt Medical Corp. Introducer Kits Micro-Access Tearaway Elite HV GaltStick Dilator

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2013-04-17
DRE	Dilator, Vessel, For Percutaneous Catheterization	Cardiovascular	Class 2	870.1310	2007-11-20
DRE	Dilator, Vessel, For Percutaneous Catheterization	Cardiovascular	Class 2	870.1310	2017-11-01
OFL	Percutaneous Sheath Introducer Kit	Cardiovascular	Class 2	870.1340	2021-12-07
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2007-11-20
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2007-11-20
DRE	Dilator, Vessel, For Percutaneous Catheterization	Cardiovascular	Class 2	870.1310	2007-11-20
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

Official Correspondent

No official correspondent registered.

US Agent Details

David Derrick Business: Galt Medical Corp Email: dderrick@galtmedical.com Phone: (214) 7781306

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
1037598	THERAGENICS CORP.	BUFORD, GA, US
1649395	GALT MEDICAL CORP.	GARLAND, TX, 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-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.

Similar Registrations

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3013764800	B. BRAUN MEDICAL INC.	Allentown, PA, US
2020394	BARD PERIPHERAL VASCULAR, INC.	TEMPE, AZ, US
3016904853	SAINT JONES MANAGEMENT LP EOOD	Sofia Sofia-Grad, BG

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011623145. Last updated year: 2026. Please use registration number 3011623145 when referencing this establishment in official correspondence.