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FDA 510(k)

CONCENTRIC HYDROPHILIC GUIDEWIRE, MODELS 90011, 90012

K-Number: K003084 · 2001-05-16

ApplicantConcentric Medical, Inc.
Decision Date2001-05-16
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CONCENTRIC HYDROPHILIC GUIDEWIRE, MODELS 90011, 90012 is the device name listed in this FDA 510(k) record. The listed applicant is Concentric Medical, Inc.. It received FDA 510(k) clearance on 2001-05-16 under 510(k) number K003084. 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 CONCENTRIC HYDROPHILIC GUIDEWIRE, MODELS 90011, 90012?

CONCENTRIC HYDROPHILIC GUIDEWIRE, MODELS 90011, 90012 is a medical device that received FDA 510(k) clearance on 2001-05-16. The listed applicant is Concentric Medical, Inc.. The 510(k) number is K003084.

When did CONCENTRIC HYDROPHILIC GUIDEWIRE, MODELS 90011, 90012 receive FDA 510(k) clearance?

CONCENTRIC HYDROPHILIC GUIDEWIRE, MODELS 90011, 90012 received FDA 510(k) clearance on 2001-05-16, under 510(k) number K003084.

Who is the listed applicant for CONCENTRIC HYDROPHILIC GUIDEWIRE, MODELS 90011, 90012?

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

What is the FDA product code for CONCENTRIC HYDROPHILIC GUIDEWIRE, MODELS 90011, 90012?

The FDA product code for CONCENTRIC HYDROPHILIC GUIDEWIRE, MODELS 90011, 90012 is DQX.

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Other records listing Concentric Medical, Inc. as applicant

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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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