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FDA 510(k)

HORIZON XVU (FFR)

K-Number: K123792 · 2013-08-30

ApplicantMennen Medical , Ltd.
Decision Date2013-08-30
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HORIZON XVU (FFR) is the device name listed in this FDA 510(k) record. The listed applicant is Mennen Medical , Ltd.. It received FDA 510(k) clearance on 2013-08-30 under 510(k) number K123792. 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 HORIZON XVU (FFR)?

HORIZON XVU (FFR) is a medical device that received FDA 510(k) clearance on 2013-08-30. The listed applicant is Mennen Medical , Ltd.. The 510(k) number is K123792.

When did HORIZON XVU (FFR) receive FDA 510(k) clearance?

HORIZON XVU (FFR) received FDA 510(k) clearance on 2013-08-30, under 510(k) number K123792.

Who is the listed applicant for HORIZON XVU (FFR)?

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

What is the FDA product code for HORIZON XVU (FFR)?

The FDA product code for HORIZON XVU (FFR) is DQX.

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Other records listing Mennen Medical , 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.

K131789CEREBRALOGIK- AEEGK093766VITALOGIK 6000/6500K091165HORIZON XVUK083063BIS INTERFACE FOR VITALOGIK PATIENT MONITORSK081484HORIZON XVUK073140VITALOGIK MODEL 4000/4500

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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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