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FDA 510(k)

STINGRAY GUIDEWIRE, STIFF, MODELS M-3003, M-3004, M-3011, M-3012

K-Number: K083727 · 2009-02-20

ApplicantBridgepoint Medical
Decision Date2009-02-20
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

STINGRAY GUIDEWIRE, STIFF, MODELS M-3003, M-3004, M-3011, M-3012 is the device name listed in this FDA 510(k) record. The listed applicant is Bridgepoint Medical. It received FDA 510(k) clearance on 2009-02-20 under 510(k) number K083727. 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 STINGRAY GUIDEWIRE, STIFF, MODELS M-3003, M-3004, M-3011, M-3012?

STINGRAY GUIDEWIRE, STIFF, MODELS M-3003, M-3004, M-3011, M-3012 is a medical device that received FDA 510(k) clearance on 2009-02-20. The listed applicant is Bridgepoint Medical. The 510(k) number is K083727.

When did STINGRAY GUIDEWIRE, STIFF, MODELS M-3003, M-3004, M-3011, M-3012 receive FDA 510(k) clearance?

STINGRAY GUIDEWIRE, STIFF, MODELS M-3003, M-3004, M-3011, M-3012 received FDA 510(k) clearance on 2009-02-20, under 510(k) number K083727.

Who is the listed applicant for STINGRAY GUIDEWIRE, STIFF, MODELS M-3003, M-3004, M-3011, M-3012?

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

What is the FDA product code for STINGRAY GUIDEWIRE, STIFF, MODELS M-3003, M-3004, M-3011, M-3012?

The FDA product code for STINGRAY GUIDEWIRE, STIFF, MODELS M-3003, M-3004, M-3011, M-3012 is DQX.

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Other records listing Bridgepoint Medical as applicant

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K122795STINGRAY GUIDEWIRESK121745MANTARAY GUIDEWIRESK120533BIGBOSS CATHETERS MANTATAY CATHETER MANTARAY GUIDEWIRESK120881MANTARAY GUIDEWIRESK120129MANTARAY CATHETERK113589BIGBOSS CATHETER

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Related Devices (Code: DQX)

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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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