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FDA 510(k)

TORAYGUIDE GUIDEWIRE

K-Number: K042370 · 2004-12-17

ApplicantToray Industries (America), Inc.
Decision Date2004-12-17
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TORAYGUIDE GUIDEWIRE is the device name listed in this FDA 510(k) record. The listed applicant is Toray Industries (America), Inc.. It received FDA 510(k) clearance on 2004-12-17 under 510(k) number K042370. 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 TORAYGUIDE GUIDEWIRE?

TORAYGUIDE GUIDEWIRE is a medical device that received FDA 510(k) clearance on 2004-12-17. The listed applicant is Toray Industries (America), Inc.. The 510(k) number is K042370.

When did TORAYGUIDE GUIDEWIRE receive FDA 510(k) clearance?

TORAYGUIDE GUIDEWIRE received FDA 510(k) clearance on 2004-12-17, under 510(k) number K042370.

Who is the listed applicant for TORAYGUIDE GUIDEWIRE?

The FDA 510(k) record lists Toray Industries (America), Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TORAYGUIDE GUIDEWIRE?

The FDA product code for TORAYGUIDE GUIDEWIRE is DQX.

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Other records listing Toray Industries (America), Inc. as applicant

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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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