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FDA 510(k)

HI-TORQUE VERSACORE GUIDE WIRE

K-Number: K083706 · 2009-02-06

ApplicantAbbott Vascular
Decision Date2009-02-06
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HI-TORQUE VERSACORE GUIDE WIRE is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Vascular. It received FDA 510(k) clearance on 2009-02-06 under 510(k) number K083706. 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 VERSACORE GUIDE WIRE?

HI-TORQUE VERSACORE GUIDE WIRE is a medical device that received FDA 510(k) clearance on 2009-02-06. The listed applicant is Abbott Vascular. The 510(k) number is K083706.

When did HI-TORQUE VERSACORE GUIDE WIRE receive FDA 510(k) clearance?

HI-TORQUE VERSACORE GUIDE WIRE received FDA 510(k) clearance on 2009-02-06, under 510(k) number K083706.

Who is the listed applicant for HI-TORQUE VERSACORE GUIDE WIRE?

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

What is the FDA product code for HI-TORQUE VERSACORE GUIDE WIRE?

The FDA product code for HI-TORQUE VERSACORE GUIDE WIRE is DQX.

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Other records listing Abbott Vascular 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.

K220634NC TREK NEO Coronary Dilatation CatheterK221057Viatrac 14 Plus Peripheral Dilatation CatheterK201834HI-TORQUE PROCEED Guide Wire FamilyK200144HI-TORQUE Steelcore Bare Guide WireK193126HI-TORQUE InfilTrac Guide Wire FamilyK191173Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery Wires

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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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