Theragenics Costa Rica Limitada

FDA Device Registration & Listing · El Coyol, Alajuela, CR · Registration 3036802499

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3036802499
FEI Number
3036802499
Entity Name
Theragenics Costa Rica Limitada
City/State/Country
El Coyol, Alajuela, CR
Establishment Address
Building B28, Module B, Zone Franca Coyol, 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
N
Expiration Date (Year)
2026
510(k) Number
K172487
PMA Number
N/A

All Registered Proprietary Names

Dilator GaltTWS Coaxial

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
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
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2019-06-06
DRB Stylet, Catheter Cardiovascular Class 2 870.1380 2019-06-06
DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass Cardiovascular Class 2 870.4290 2019-06-06
DRE Dilator, Vessel, For Percutaneous Catheterization Cardiovascular Class 2 870.1310 2017-11-01

Official Correspondent

No official correspondent registered.

US Agent Details

David Derrick Business: Galt Medical 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
3011623145 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.
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 3036802499. Last updated year: 2026. Please use registration number 3036802499 when referencing this establishment in official correspondence.
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