Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016257349

FEI Number

3016257349

Entity Name

Philips Image Guided Therapy Corporation

City/State/Country

Plymouth, MN, US

Establishment Address

5905 Nathan Lane North, Plymouth, MN 55442, US

Establishment Type(s)

Manufacture Medical Device,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Philips Medical Systems International BV (Owner Number: 2939520)

Owner / Operator Contact Address

Veenpluis 6, Best, NL-NOTA 5684PC, NL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K211518

PMA Number

N/A

All Registered Proprietary Names

Phoenix Handle with Wire Support Clip Phoenix Pre-Deflected Atherectomy System 2.2mm x 130cm Phoenix Pre-Deflected Atherectomy Catheter 2.2mm x 130cm Duo Venous Stent System Stellarex 035 OTW Drug-coated Angioplasty Balloon Stellarex Drug-Coated Angioplasty Balloon Bridge Plus Occlusion Balloon Catheter Phoenix Pre-Deflected Atherectomy System 2.4mm x 130cm Phoenix Atherectomy System 1.5mm x 149cm Phoenix Pre-Deflected Atherectomy Catheter 2.4mm x 130cm Phoenix Handle with Wire Support Clip Phoenix Atherectomy Catheter 1.5mm x 149cm

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MCW	Catheter, Peripheral, Atherectomy	Cardiovascular	Class 2	870.4875	2019-03-15
QAN	Stent, Iliac Vein	Unknown	Class 3	N/A	2025-11-21
ONU	Drug-Eluting Peripheral Transluminal Angioplasty Catheter	Unknown	Class 3	N/A	2018-11-26
MJN	Catheter, Intravascular Occluding, Temporary	Cardiovascular	Class 2	870.4450	2025-09-22
MCW	Catheter, Peripheral, Atherectomy	Cardiovascular	Class 2	870.4875	2021-10-19

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Philips Medical Systems International BV

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3038281851	Philips Polska Sp. z o.o.	Lodz Lodzkie, PL
3003584029	Braemar Manufacturing, LLC	San Diego, CA, US
3042175841	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.	Best Noord-Brabant, NL
3008514395	Telcare, LLC	Linwood, PA, US
3004961434	RESPIRATORY TECHNOLOGIES, INC.	Plymouth, MN, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K051067	LeMaitre Vascular, Inc.	PRUITT F3 OUTLYING AND INLYING CAROTID SHUNT (WITH AND WITHOUT T-PORT)	2005-05-27
K093847	Thermopeutix, Inc.	DUFLO CATHETER (HEPARIN COATED)	2010-08-25

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0013-2009	Edwards Lifesciences, LLC	2	Edwards Lifesciences*Fogarty Fortis*Arterial Embolectomy Catheter Is indicated for the removal of fresh, soft emboli and thrombi from the vessels in the arterial system.

Similar Registrations

Registration Number	Establishment Name	Location
3003862657	REX MEDICAL LP	CONSHOHOCKEN, PA, US
3004091615	Abbott Vascular Netherlands	Heerlen Limburg, NL
3002807314	Synergy Health Ireland Ltd	Tullamore Offaly, IE
2011171	Sterigenics US LLC	Los Angeles, CA, US
3012669557	LIGHT GUIDE OPTICS INTERNATIONAL LTD.	Livani Preilu Novads, LV

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016257349. Last updated year: 2026. Please use registration number 3016257349 when referencing this establishment in official correspondence.