Data / Medical devices / United States / Philips Image Guided Therapy Corporation

Philips Image Guided Therapy Corporation: FDA-registered device maker in Plymouth, MN, United States, 3 510(k) clearances and 2 PMA approvals

Name: Philips Image Guided Therapy Corporation FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Philips Image Guided Therapy Corporation is registered with the FDA (registration 3016257349) in Plymouth, MN, United States. It lists 4 device types. The FDA files 3 510(k) clearances and 2 PMA approvals under its listings, the newest dated June 24, 2025. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this one Watch Philips Image Guided Therapy Corporation

FDA registration number: 3016257349
Address: 5905 Nathan Lane North, Plymouth, MN, United States, 55442
Owner or operator: Philips Medical Systems International BV (2939520)
Roles: Complaint file establishment, Manufacturer, Specification developer
First device listed: November 26, 2018
Registered through: 2026
Brand names listed: Bridge Plus Occlusion Balloon Catheter, Duo Venous Stent System, Phoenix Atherectomy Catheter 1.5mm x 149cm, Phoenix Atherectomy System 1.5mm x 149cm, Phoenix Handle with Wire Support Clip, Phoenix Pre-Deflected Atherectomy Catheter 2.2mm x 130cm, Phoenix Pre-Deflected Atherectomy Catheter 2.4mm x 130cm, Phoenix Pre-Deflected Atherectomy System 2.2mm x 130cm and more

Devices it lists

Device	Product code	Class	Role	Source
Catheter, Intravascular Occluding, Temporary	MJN	2	Manufacturer	accessdata.fda.gov
Catheter, Peripheral, Atherectomy	MCW	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Drug-Eluting Peripheral Transluminal Angioplasty Catheter	ONU	3	Complaint file establishment, Manufacturer	accessdata.fda.gov
Stent, Iliac Vein	QAN	3	Complaint file establishment, Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
June 24, 2025	K251358	Bridge Plus Occlusion Balloon (590-002)	MJN	Substantially Equivalent	Philips Image Guided Therapy Devices	accessdata.fda.gov
June 14, 2021	K211518	2.4mm X 130cm Phoenix Deflecting Atherectomy System, 1.5mm X 149cm Phoenix Atherectomy System	MCW	Substantially Equivalent	Volcano Atheromed, Inc.	accessdata.fda.gov
December 20, 2018	K182972	Phoenix Atherectomy System	MCW	Substantially Equivalent	Volcano Atheromed, Inc.	accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
December 26, 2023	P230021	Duo Venous Stent System	QAN	4	August 26, 2026	accessdata.fda.gov
July 26, 2017	P160049	STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOON	ONU	24	March 19, 2026	accessdata.fda.gov

Compare with other makers

Updated August 26, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.