Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Lunderquist Extra Stiff Wire Guide

K-Number: K251596 · 2025-11-09

ApplicantWilliam Cook Europe Aps
Decision Date2025-11-09
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Lunderquist Extra Stiff Wire Guide is a medical device manufactured by William Cook Europe Aps. It received FDA 510(k) clearance on 2025-11-09 under approval number K251596. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Lunderquist Extra Stiff Wire Guide?

Lunderquist Extra Stiff Wire Guide is a medical device that received FDA 510(k) clearance on 2025-11-09. It is manufactured by William Cook Europe Aps. The 510(k) number is K251596.

When was Lunderquist Extra Stiff Wire Guide approved by the FDA?

Lunderquist Extra Stiff Wire Guide received FDA 510(k) clearance on 2025-11-09, under approval number K251596.

What company makes Lunderquist Extra Stiff Wire Guide?

Lunderquist Extra Stiff Wire Guide is manufactured by William Cook Europe Aps.

What is the FDA product code for Lunderquist Extra Stiff Wire Guide?

The FDA product code for Lunderquist Extra Stiff Wire Guide is DQX.

Related Clinical Trials

NCT07572253 A Study of Using CARTO SOUND™ FAM to Guide Pulsed Field Ablation for Atrial Fibrillation NOT_YET_RECRUITING

Other Devices by William Cook Europe Aps

K171513Lunderquist Extra Stiff Wire Guide K172584Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach K172557Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach, Gunther Tulip Vena Cava Filter Set for Jugular Vein Approach, Gunther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach K171712Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Cook Celect Platinum Vena Cava Filter Set for Jugular Vein Approach, Cook Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach K161813Frova Intubating Introducer K211875Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Cook Celect Platinum Vena Cava Filte Set for Jugular Vein Approach, Cook Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach

View all 13 devices →

Related Devices (Code: DQX)

K160785Worker GuidewireArgon Medical Devices, Inc. K161702Endura guidewireVascular Solutions, Inc. K160594MRWire Guide WireNano4imaging GmbH K160643ENROUTE 0.014 GuidewireLake Region Medical K153685Sunmed Haemostatic ValvesSunny Medical Device (Shenzhen) Co., Ltd. K161584ASAHI® Peripheral Vascular Guide Wire ASAHI Meister®16Asahi Intecc Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑