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Pre-Formed Guidewire — Lake Region Medical (510(k) K151244)

Pre-Formed Guidewire — Lake Region Medical (510(k) K151244) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: Pre-Formed Guidewire; Applicant: Lake Region Medical; Clearance track: 510(k).

Device namePre-Formed Guidewire
ApplicantLake Region Medical
Clearance track510(k)
Submission numberK151244
DecisionSubstantially Equivalent
Decision date2015-06-11
Date received2015-05-11
Product codeDQX
Device class2
Medical specialtyCardiovascular
Applicant locationMN, US
SourceopenFDA device

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