Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009766315

FEI Number

3009766315

Entity Name

QXMEDICAL, LLC

City/State/Country

Saint Paul, MN, US

Establishment Address

2820 Patton Rd, Saint Paul, MN 55113, US

Establishment Type(s)

Manufacture Device in the United States for Export Only

Owner / Operator

QXMedical, LLC (Owner Number: 10041546)

Owner / Operator Contact Address

2820 Patton Road, Saint Paul, MN 55113, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Boosting Catheter

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GXI	Probe, Radiofrequency Lesion	Neurology	Class 2	882.4725	2025-09-05
MJN	Catheter, Intravascular Occluding, Temporary	Cardiovascular	Class 2	870.4450	2019-05-16
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2016-11-22
GYC	Electrode, Cortical	Neurology	Class 2	882.1310	2020-12-18
GZL	Electrode, Depth	Neurology	Class 2	882.1330	2022-05-27
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2021-12-27

Official Correspondent

Fernando Di Caprio

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

QXMedical, LLC

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
K253907	ABBOTT MEDICAL	Disposable Radiofrequency Cannula	2026-04-16
K242841	ABBOTT MEDICAL	Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20)	2025-05-27
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
K043580	Chestnut Medical Technologies, Inc.	ALLIGATOR RETRIEVAL DEVICE (ARD)	2005-03-24

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0720-2020	Abbott Medical	2	CLASSIC Radiofrequency Cannula - Curved, 10 cm, SMK Compatible Electrode, REF C-1005-S - Product Usage: Disposable Radiofrequency Cannulae are provided in either straight, curved, or curved blunt geometries with a stylet inserted in the cannula. Cannulae are insulated except for the active tip. The active tip determines the size of the radiofrequency lesion.
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.
Z-0001-2010	Penumbra Inc.	2	Penumbra Neuron Delivery Catheter 070, percutaneous catheter, catalog numbers PND6F0701058, PND6F070956, PND6F0701058M, and PND6F070956M; manufactured by Penumbra, Inc., Alameda, CA. Indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
Z-0003-2014	Cordis Corporation	2	Cordis ADROIT 6F Guiding Catheter Product Usage: For intravascular introduction of interventional and/or diagnostic devices into the coronary or peripheral vascular system.
Z-0009-2024	Boston Scientific Corporation	2	Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420, cardiac guide catheter

Similar Registrations

Registration Number	Establishment Name	Location
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3030733800	AD SUPPLY GROUP LIMITED	London London, City of, GB
3006950086	Merit Medical Nederland BV	Maastricht Airport Limburg, NL
3010034260	SCIENTIFIC MOLDING CORPORATION LTD. DBA SMC LTD.	Santa Rosa, CA, US
8010177	STRYKER LEIBINGER GMBH & CO. KG	FREIBURG Baden-Wurttemberg, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009766315. Last updated year: 2026. Please use registration number 3009766315 when referencing this establishment in official correspondence.