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FDA 510(k)

Lunderquist Extra Stiff Wire Guide

K-Number: K220137 · 2022-02-17

ApplicantWilliam Cook Europe Aps
Decision Date2022-02-17
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Lunderquist Extra Stiff Wire Guide is the device name listed in this FDA 510(k) record. The listed applicant is William Cook Europe Aps. It received FDA 510(k) clearance on 2022-02-17 under 510(k) number K220137. 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 2022-02-17. The listed applicant is William Cook Europe Aps. The 510(k) number is K220137.

When did Lunderquist Extra Stiff Wire Guide receive FDA 510(k) clearance?

Lunderquist Extra Stiff Wire Guide received FDA 510(k) clearance on 2022-02-17, under 510(k) number K220137.

Who is the listed applicant for Lunderquist Extra Stiff Wire Guide?

The FDA 510(k) record lists William Cook Europe Aps as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing William Cook Europe Aps as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

PMA P180001SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENTK251596Lunderquist Extra Stiff Wire GuideK251499Frova Intubating Introducer (C-CAE-14.0-70-FII); Frova Intubating Introducer (C-CAE-14.0-70-FI); Frova Intubating Introducer (C-CAE-14.0-70-FIC); Frova Intubating Introducer (C-CAE-14.0-70-FIC-SPOPS)K233680Celect Platinum Vena Cava Filter Set for Femoral Vein Approach (IGTCFS-65-1-FEM-CELECT-PT); Celect Platinum Vena Cava Filter Set for Jugular Vein Approach (IGTCFS-65-1-JUG-CELECT-PT); Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach (IGTCFS-65-1-UNI-CELECT-PT); Günther Tulip Vena Cava Filter Set for Femoral Vein Approach (IGTCFS-65-1-FEM-TULIP); Günther Tulip Vena Cava Filter Set for Jugular Vein Approach (IGTCFS-65-1-JUG-TULIP); Günther Tulip Vena Cava FilterK211875Cook 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 ApproachK211874Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip Vena Cava Filter Set for Jugular Vein Approach, Günther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach

View all 13 devices →

Related Devices (Code: DQX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253667Accoat Guide WireSp Medical A/SK261640Merit MAK Nitinol/Gold-Tungsten Guide WireMerit Medical Ireland , Ltd.K254137InQwire Amplatz Guide WireMerit Medical Ireland, Ltd.K260544FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40; FMD Peripheral Guide Wire F-18 Flex SP; FMD Peripheral Guide Wire F-18 DP 25; FMD Peripheral Guide Wire F-18 Tapered 40FMD Co., Ltd.K253746Enroute 0.014'' Transcarotid GuidewireLake Region MedicalK253262EmeryGlide™ (EG18008901)Nano4imaging GmbH

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.

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