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FDA 510(k)

CRUISER 18 GUIDEWIRE

K-Number: K102211 · 2010-09-03

ApplicantBrivant, Ltd.
Decision Date2010-09-03
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CRUISER 18 GUIDEWIRE is the device name listed in this FDA 510(k) record. The listed applicant is Brivant, Ltd.. It received FDA 510(k) clearance on 2010-09-03 under 510(k) number K102211. 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 CRUISER 18 GUIDEWIRE?

CRUISER 18 GUIDEWIRE is a medical device that received FDA 510(k) clearance on 2010-09-03. The listed applicant is Brivant, Ltd.. The 510(k) number is K102211.

When did CRUISER 18 GUIDEWIRE receive FDA 510(k) clearance?

CRUISER 18 GUIDEWIRE received FDA 510(k) clearance on 2010-09-03, under 510(k) number K102211.

Who is the listed applicant for CRUISER 18 GUIDEWIRE?

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 CRUISER 18 GUIDEWIRE?

The FDA product code for CRUISER 18 GUIDEWIRE 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)K103377CHARTER GUIDEWIRE MODEL 45-281, 45-282, 45-283K0935153 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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