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FDA 510(k)

GUIDED WIRE TORQUER

K-Number: K860840 · 1986-04-23

ApplicantTarget Therapeutics
Decision Date1986-04-23
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

GUIDED WIRE TORQUER is the device name listed in this FDA 510(k) record. The listed applicant is Target Therapeutics. It received FDA 510(k) clearance on 1986-04-23 under 510(k) number K860840. 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 GUIDED WIRE TORQUER?

GUIDED WIRE TORQUER is a medical device that received FDA 510(k) clearance on 1986-04-23. The listed applicant is Target Therapeutics. The 510(k) number is K860840.

When did GUIDED WIRE TORQUER receive FDA 510(k) clearance?

GUIDED WIRE TORQUER received FDA 510(k) clearance on 1986-04-23, under 510(k) number K860840.

Who is the listed applicant for GUIDED WIRE TORQUER?

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

What is the FDA product code for GUIDED WIRE TORQUER?

The FDA product code for GUIDED WIRE TORQUER is DQX.

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Other records listing Target Therapeutics 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)

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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