ARBOR ENDOVASCULAR

FDA Device Registration & Listing · San Jose, CA, US · Registration 3039642752

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
3039642752
FEI Number
3039642752
Entity Name
ARBOR ENDOVASCULAR
City/State/Country
San Jose, CA, US
Establishment Address
2345 Bering Dr, San Jose, CA 95131, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198
Owner / Operator
Arbor Endovascular (Owner Number: 10093944)
Owner / Operator Contact Address
2345 Bering Drive, San Jose, CA 95131, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K260537
PMA Number
N/A

All Registered Proprietary Names

Willow 18 Guidewire Willow 14 Guidewire 014" Willow Guidewire 14 Willow Wire Willow 14 Guidewire 014" Willow Guidewire Willow 24 Guidewire

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MOF Guide, Wire, Catheter, Neurovasculature Cardiovascular Class 2 870.1330 2026-03-04
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2026-03-04
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2026-05-22
MOF Guide, Wire, Catheter, Neurovasculature Cardiovascular Class 2 870.1330 2026-05-22
MOF Guide, Wire, Catheter, Neurovasculature Cardiovascular Class 2 870.1330 2025-08-15
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2025-08-15
MOF Guide, Wire, Catheter, Neurovasculature Cardiovascular Class 2 870.1330 2026-05-22
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2026-05-22

Official Correspondent

Kathy Tansey

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Arbor Endovascular
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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3009121749 ASAHI INTECC HANOI CO., LTD. Hanoi Ha Noi, VN
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3039642752. Last updated year: 2026. Please use registration number 3039642752 when referencing this establishment in official correspondence.
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