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FDA 510(k)

HI TORQUE CONNECT GUIDEWIRE

K-Number: K112381 · 2011-11-03

ApplicantLake Region Medical
Decision Date2011-11-03
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HI TORQUE CONNECT GUIDEWIRE is the device name listed in this FDA 510(k) record. The listed applicant is Lake Region Medical. It received FDA 510(k) clearance on 2011-11-03 under 510(k) number K112381. 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 CONNECT GUIDEWIRE?

HI TORQUE CONNECT GUIDEWIRE is a medical device that received FDA 510(k) clearance on 2011-11-03. The listed applicant is Lake Region Medical. The 510(k) number is K112381.

When did HI TORQUE CONNECT GUIDEWIRE receive FDA 510(k) clearance?

HI TORQUE CONNECT GUIDEWIRE received FDA 510(k) clearance on 2011-11-03, under 510(k) number K112381.

Who is the listed applicant for HI TORQUE CONNECT GUIDEWIRE?

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

What is the FDA product code for HI TORQUE CONNECT GUIDEWIRE?

The FDA product code for HI TORQUE CONNECT GUIDEWIRE is DQX.

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Other records listing Lake Region Medical 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.

K253746Enroute 0.014'' Transcarotid GuidewireK242824PTFE GuidewireK221575Pre-Formed BlueK211741Pre-Formed Extra Support GuidewireK160643ENROUTE 0.014 GuidewireK124052OSTAVI HYDROPHILIC GUIDEWIRE

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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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