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FDA 510(k)

MANDREL GUIDEWIRE ASSEMBLY

K-Number: K011084 · 2001-05-10

ApplicantLake Region Mfg., Inc.
Decision Date2001-05-10
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MANDREL GUIDEWIRE ASSEMBLY is the device name listed in this FDA 510(k) record. The listed applicant is Lake Region Mfg., Inc.. It received FDA 510(k) clearance on 2001-05-10 under 510(k) number K011084. 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 MANDREL GUIDEWIRE ASSEMBLY?

MANDREL GUIDEWIRE ASSEMBLY is a medical device that received FDA 510(k) clearance on 2001-05-10. The listed applicant is Lake Region Mfg., Inc.. The 510(k) number is K011084.

When did MANDREL GUIDEWIRE ASSEMBLY receive FDA 510(k) clearance?

MANDREL GUIDEWIRE ASSEMBLY received FDA 510(k) clearance on 2001-05-10, under 510(k) number K011084.

Who is the listed applicant for MANDREL GUIDEWIRE ASSEMBLY?

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

What is the FDA product code for MANDREL GUIDEWIRE ASSEMBLY?

The FDA product code for MANDREL GUIDEWIRE ASSEMBLY is DQX.

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Other records listing Lake Region Mfg., 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.

K092965TRAILRUNNER GUIDEWIRESK082922FREEWAY AND RAILRUNNER GUIDEWIRESK081708TAXI ENDOSCOPIC GUIDEWIREK080144MANDREL GUIDEWIRES OR M-WIRESK073655PEGASUS STEERABLE (PTCA) GUIDEWIREK060454TITAN 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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