Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1221806

FEI Number

1221806

Entity Name

GUIDEWIRE TECHNOLOGIES, INC.

City/State/Country

SALEM, NH, US

Establishment Address

26 KEEWAYDIN DR., SALEM, NH 03079, US

Establishment Type(s)

Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

GUIDEWIRE TECHNOLOGIES, INC. (Owner Number: 1221806)

Owner / Operator Contact Address

26 KEEWAYDIN DR., --, SALEM, NH 03079, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K890959

PMA Number

N/A

All Registered Proprietary Names

PTFE Coated Guidewire Uncoated Guidewire

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2007-12-10
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2007-12-10

Official Correspondent

DOUGLAS CURTIS

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

GUIDEWIRE TECHNOLOGIES, INC.

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

View Entity Profile →

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.

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3018070217	SHANGHAI ACHIEVA MEDICAL SUZHOU CO., LTD.	Suzhou Jiangsu, CN
3015522130	NANO4IMAGING USA, LLC.	Dublin, OH, US
3007635982	Confluent Medical Technologies, Inc	Fremont, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1221806. Last updated year: 2026. Please use registration number 1221806 when referencing this establishment in official correspondence.