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FDA 510(k)

TORAY SUPERSELECTIVE GUIDEWIRE,SUPERSELEC Y-K TYPE

K-Number: K861115 · 1986-07-11

ApplicantToray Industries (America), Inc.
Decision Date1986-07-11
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TORAY SUPERSELECTIVE GUIDEWIRE,SUPERSELEC Y-K TYPE 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 1986-07-11 under 510(k) number K861115. 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 TORAY SUPERSELECTIVE GUIDEWIRE,SUPERSELEC Y-K TYPE?

TORAY SUPERSELECTIVE GUIDEWIRE,SUPERSELEC Y-K TYPE is a medical device that received FDA 510(k) clearance on 1986-07-11. The listed applicant is Toray Industries (America), Inc.. The 510(k) number is K861115.

When did TORAY SUPERSELECTIVE GUIDEWIRE,SUPERSELEC Y-K TYPE receive FDA 510(k) clearance?

TORAY SUPERSELECTIVE GUIDEWIRE,SUPERSELEC Y-K TYPE received FDA 510(k) clearance on 1986-07-11, under 510(k) number K861115.

Who is the listed applicant for TORAY SUPERSELECTIVE GUIDEWIRE,SUPERSELEC Y-K TYPE?

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 TORAY SUPERSELECTIVE GUIDEWIRE,SUPERSELEC Y-K TYPE?

The FDA product code for TORAY SUPERSELECTIVE GUIDEWIRE,SUPERSELEC Y-K TYPE is DQX.

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

K042370TORAYGUIDE GUIDEWIREK030050TORAYSULFONE DIALYZER, BS-L SERIESK002512TORAYSULFONE DIALYZERK994198HEMOFEEL-CH, MODELS CH-0.35L, CH-0.6L, CH-1.0LK942681FILTRYZERK935471FILTRYZER(TM)

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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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