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FDA 510(k)

RADIUS 018 COUGAR WIRE

K-Number: K032129 · 2003-07-17

ApplicantRadius Medical Technologies, Inc.
Decision Date2003-07-17
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

RADIUS 018 COUGAR WIRE is the device name listed in this FDA 510(k) record. The listed applicant is Radius Medical Technologies, Inc.. It received FDA 510(k) clearance on 2003-07-17 under 510(k) number K032129. 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 RADIUS 018 COUGAR WIRE?

RADIUS 018 COUGAR WIRE is a medical device that received FDA 510(k) clearance on 2003-07-17. The listed applicant is Radius Medical Technologies, Inc.. The 510(k) number is K032129.

When did RADIUS 018 COUGAR WIRE receive FDA 510(k) clearance?

RADIUS 018 COUGAR WIRE received FDA 510(k) clearance on 2003-07-17, under 510(k) number K032129.

Who is the listed applicant for RADIUS 018 COUGAR WIRE?

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

What is the FDA product code for RADIUS 018 COUGAR WIRE?

The FDA product code for RADIUS 018 COUGAR WIRE is DQX.

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Other records listing Radius Medical Technologies, Inc. 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.

K070502RADIUS SNAREK071457MODIFICATION TO RADIUS SNAREK032899RADIUS COUGAR WIREK022201RADIUS MICRO SNAREK021441RADIUS SNAREK011759RADIUS NEXT GENERATION GUIDEWIRE

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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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