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FDA 510(k)

ASAHI TREASURE FLOPPY PERIPHERAL GUIDE WIRE

K-Number: K110553 · 2011-03-18

ApplicantAsahi Intecc USA, Inc.
Decision Date2011-03-18
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ASAHI TREASURE FLOPPY PERIPHERAL GUIDE WIRE is the device name listed in this FDA 510(k) record. The listed applicant is Asahi Intecc USA, Inc.. It received FDA 510(k) clearance on 2011-03-18 under 510(k) number K110553. 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 ASAHI TREASURE FLOPPY PERIPHERAL GUIDE WIRE?

ASAHI TREASURE FLOPPY PERIPHERAL GUIDE WIRE is a medical device that received FDA 510(k) clearance on 2011-03-18. The listed applicant is Asahi Intecc USA, Inc.. The 510(k) number is K110553.

When did ASAHI TREASURE FLOPPY PERIPHERAL GUIDE WIRE receive FDA 510(k) clearance?

ASAHI TREASURE FLOPPY PERIPHERAL GUIDE WIRE received FDA 510(k) clearance on 2011-03-18, under 510(k) number K110553.

Who is the listed applicant for ASAHI TREASURE FLOPPY PERIPHERAL GUIDE WIRE?

The FDA 510(k) record lists Asahi Intecc USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ASAHI TREASURE FLOPPY PERIPHERAL GUIDE WIRE?

The FDA product code for ASAHI TREASURE FLOPPY PERIPHERAL GUIDE WIRE is DQX.

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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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