FDA 510(k)

Approach CTO Microwire Guide

K-Number: K171897 · 2017-08-21

Decision Date2017-08-21

Product CodeDQX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Approach CTO Microwire Guide is the device name listed in this FDA 510(k) record. The listed applicant is Cook Incorporated. It received FDA 510(k) clearance on 2017-08-21 under 510(k) number K171897. 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 Approach CTO Microwire Guide?

Approach CTO Microwire Guide is a medical device that received FDA 510(k) clearance on 2017-08-21. The listed applicant is Cook Incorporated. The 510(k) number is K171897.

When did Approach CTO Microwire Guide receive FDA 510(k) clearance?

Approach CTO Microwire Guide received FDA 510(k) clearance on 2017-08-21, under 510(k) number K171897.

Who is the listed applicant for Approach CTO Microwire Guide?

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

What is the FDA product code for Approach CTO Microwire Guide?

The FDA product code for Approach CTO Microwire Guide is DQX.

Other records listing Cook Incorporated 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 P020018SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT K233177Nest VT Vitrification Device K222254Gunther Tulip Vena Cava Filter Retrieval Set K223098Bakri Essential Postpartum Balloon K210734Endovascular Dilator and Sets K203670Extra Large Check-Flo Introducer

View all 147 devices →

Related Devices (Code: DQX)

K253667Accoat Guide WireSp Medical A/S K261640Merit 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 Medical K253262EmeryGlide™ (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.