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FDA 510(k)

CONDUCTOR CORONARY GUIDEWIRE

K-Number: K090193 · 2009-09-25

ApplicantConcert Medical, LLC
Decision Date2009-09-25
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CONDUCTOR CORONARY GUIDEWIRE is the device name listed in this FDA 510(k) record. The listed applicant is Concert Medical, LLC. It received FDA 510(k) clearance on 2009-09-25 under 510(k) number K090193. 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 CONDUCTOR CORONARY GUIDEWIRE?

CONDUCTOR CORONARY GUIDEWIRE is a medical device that received FDA 510(k) clearance on 2009-09-25. The listed applicant is Concert Medical, LLC. The 510(k) number is K090193.

When did CONDUCTOR CORONARY GUIDEWIRE receive FDA 510(k) clearance?

CONDUCTOR CORONARY GUIDEWIRE received FDA 510(k) clearance on 2009-09-25, under 510(k) number K090193.

Who is the listed applicant for CONDUCTOR CORONARY GUIDEWIRE?

The FDA 510(k) record lists Concert Medical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CONDUCTOR CORONARY GUIDEWIRE?

The FDA product code for CONDUCTOR CORONARY GUIDEWIRE is DQX.

Related Clinical Trials

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.

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Other records listing Concert Medical, LLC 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.

K153599Concert Medical Hands-Free Syringe (HFS)K153397S-Wire Guidewire System

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.

K253146Hyperdrive 35 GuidewireRapid-Medical , Ltd.K261281CROSSLEAD Standard 035 and CROSSLEAD Stiff 035Filmecc Co., Ltd.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.

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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