NeedleTech Products, Inc.

FDA Device Registration & Listing · N Attleboro, MA, US · Registration 3006283319

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
3006283319
FEI Number
3006283319
Entity Name
NeedleTech Products, Inc.
City/State/Country
N Attleboro, MA, US
Establishment Address
452 John L Dietsch Blvd, N Attleboro, MA 02763, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
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
N/A
PMA Number
N/A

All Registered Proprietary Names

GUIDEWIRE INTRODUCER NEEDLE Galt Medical Guidewire Micro-Access Tearaway Coaxial GaltStick CATHATER NEEDLE Guidewire Elite HV CATHATER NEEDLE Nitinol Guidewires (Mandrel)

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2007-11-20
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 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 2007-11-20
GAA Needle, Aspiration And Injection, Disposable General, Plastic Surgery Class 1 878.4800 2008-12-24
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2024-07-17
MOF Guide, Wire, Catheter, Neurovasculature Cardiovascular Class 2 870.1330 2024-07-17
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2007-11-20
OAR Injector, Vertebroplasty (Does Not Contain Cement) Orthopedic Class 1 888.4200 2008-12-24
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 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
1649395 GALT MEDICAL CORP. GARLAND, TX, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K150445 Asahi Intecc Co., Ltd. ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd, ASAHI Gaia PV) 2015-06-30
K082922 Lake Region Mfg., Inc. FREEWAY AND RAILRUNNER GUIDEWIRES 2008-12-09
K890207 E-Z-Em, Inc. INTERVENTIONAL PRODUCTS - GUIDE WIRES 1989-05-31
K992169 Advanced Cardiovascular Systems, Inc. ACS HI-TORQUE CROSS-IT 400XT GUIDE WIRE 1999-10-28
K012534 Advanced Cardiovascular Systems, Inc. HI-TORQUE MIDDLE SUPPORT .012 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING 2002-01-24

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
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.
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-0017-2023 Hobbs Medical, Inc. 1
Hobbs Transbronchial Aspiration Needle and Vacu-lok Aspirating Syringe Catalog Number: 4620

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006283319. Last updated year: 2026. Please use registration number 3006283319 when referencing this establishment in official correspondence.
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