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FDA 510(k)

CHARTER GUIDEWIRE MODEL 45-281, 45-282, 45-283

K-Number: K103377 · 2011-05-18

ApplicantBrivant, Ltd.
Decision Date2011-05-18
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CHARTER GUIDEWIRE MODEL 45-281, 45-282, 45-283 is the device name listed in this FDA 510(k) record. The listed applicant is Brivant, Ltd.. It received FDA 510(k) clearance on 2011-05-18 under 510(k) number K103377. 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 CHARTER GUIDEWIRE MODEL 45-281, 45-282, 45-283?

CHARTER GUIDEWIRE MODEL 45-281, 45-282, 45-283 is a medical device that received FDA 510(k) clearance on 2011-05-18. The listed applicant is Brivant, Ltd.. The 510(k) number is K103377.

When did CHARTER GUIDEWIRE MODEL 45-281, 45-282, 45-283 receive FDA 510(k) clearance?

CHARTER GUIDEWIRE MODEL 45-281, 45-282, 45-283 received FDA 510(k) clearance on 2011-05-18, under 510(k) number K103377.

Who is the listed applicant for CHARTER GUIDEWIRE MODEL 45-281, 45-282, 45-283?

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

What is the FDA product code for CHARTER GUIDEWIRE MODEL 45-281, 45-282, 45-283?

The FDA product code for CHARTER GUIDEWIRE MODEL 45-281, 45-282, 45-283 is DQX.

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Other records listing Brivant, Ltd. 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.

K122856CHARTER GUIDEWIREK120137VICTORY GUIDEWIRE (32 MODELS)K102211CRUISER 18 GUIDEWIREK0935153 PIECE PARODI GUIDEWIRE SYSTEM ( LONG CUT OUTER WITH LONG TAPER .014) SHORT TAPER, 2 PIECE PARODI GUIDEWIRE SYSTEM (LONK083094STREAMER POLYMER GUIDEWIREK073082CPS COURIER 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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