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FDA 510(k)

HI-TORQUE ADVANCE AND ADVANCE LITE GUIDE WIRE

K-Number: K060449 · 2006-05-30

ApplicantGuidant Corporation
Decision Date2006-05-30
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HI-TORQUE ADVANCE AND ADVANCE LITE GUIDE WIRE is the device name listed in this FDA 510(k) record. The listed applicant is Guidant Corporation. It received FDA 510(k) clearance on 2006-05-30 under 510(k) number K060449. 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 HI-TORQUE ADVANCE AND ADVANCE LITE GUIDE WIRE?

HI-TORQUE ADVANCE AND ADVANCE LITE GUIDE WIRE is a medical device that received FDA 510(k) clearance on 2006-05-30. The listed applicant is Guidant Corporation. The 510(k) number is K060449.

When did HI-TORQUE ADVANCE AND ADVANCE LITE GUIDE WIRE receive FDA 510(k) clearance?

HI-TORQUE ADVANCE AND ADVANCE LITE GUIDE WIRE received FDA 510(k) clearance on 2006-05-30, under 510(k) number K060449.

Who is the listed applicant for HI-TORQUE ADVANCE AND ADVANCE LITE GUIDE WIRE?

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

What is the FDA product code for HI-TORQUE ADVANCE AND ADVANCE LITE GUIDE WIRE?

The FDA product code for HI-TORQUE ADVANCE AND ADVANCE LITE GUIDE WIRE is DQX.

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Other records listing Guidant Corporation 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.

K053459OMNILINK .035 BILIARY STENT SYSTEMK053454RX HERCULINK ELITE BILIARY STENT SYSTEMK053019ACUITY STEERABLE STYLET ACCESSORYK052965EASYTRAK 2 STYLET, MODELS 4826, 4829, 4832.K052274GUIDANT VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING SYSTEM, MODEL VH-3000K052166MODIFICATION TO: RX ACCUNET EMBOLIC PROTECTION SYSTEM

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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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