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FDA 510(k)

RADIUS COUGAR WIRE

K-Number: K011287 · 2001-05-25

ApplicantRadius Medical Technologies, Inc.
Decision Date2001-05-25
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

RADIUS 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 2001-05-25 under 510(k) number K011287. 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 COUGAR WIRE?

RADIUS COUGAR WIRE is a medical device that received FDA 510(k) clearance on 2001-05-25. The listed applicant is Radius Medical Technologies, Inc.. The 510(k) number is K011287.

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

RADIUS COUGAR WIRE received FDA 510(k) clearance on 2001-05-25, under 510(k) number K011287.

Who is the listed applicant for RADIUS 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 COUGAR WIRE?

The FDA product code for RADIUS 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 WIREK032129RADIUS 018 COUGAR WIREK022201RADIUS MICRO SNAREK021441RADIUS SNARE

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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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