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FDA 510(k)

RADIFOCUS GLIDEWIRE GT WITH GOLD COIL,GLIDEWIRE GOLD

K-Number: K955801 · 1996-02-02

ApplicantTerumo Medical Corp.
Decision Date1996-02-02
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

RADIFOCUS GLIDEWIRE GT WITH GOLD COIL,GLIDEWIRE GOLD is the device name listed in this FDA 510(k) record. The listed applicant is Terumo Medical Corp.. It received FDA 510(k) clearance on 1996-02-02 under 510(k) number K955801. 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 RADIFOCUS GLIDEWIRE GT WITH GOLD COIL,GLIDEWIRE GOLD?

RADIFOCUS GLIDEWIRE GT WITH GOLD COIL,GLIDEWIRE GOLD is a medical device that received FDA 510(k) clearance on 1996-02-02. The listed applicant is Terumo Medical Corp.. The 510(k) number is K955801.

When did RADIFOCUS GLIDEWIRE GT WITH GOLD COIL,GLIDEWIRE GOLD receive FDA 510(k) clearance?

RADIFOCUS GLIDEWIRE GT WITH GOLD COIL,GLIDEWIRE GOLD received FDA 510(k) clearance on 1996-02-02, under 510(k) number K955801.

Who is the listed applicant for RADIFOCUS GLIDEWIRE GT WITH GOLD COIL,GLIDEWIRE GOLD?

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

What is the FDA product code for RADIFOCUS GLIDEWIRE GT WITH GOLD COIL,GLIDEWIRE GOLD?

The FDA product code for RADIFOCUS GLIDEWIRE GT WITH GOLD COIL,GLIDEWIRE GOLD is DQX.

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Other records listing Terumo Medical Corp. 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.

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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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