FDA 510(k) Application Details - K201695

Device Classification Name Clamp, Vascular

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510(K) Number K201695
Device Name Clamp, Vascular
Applicant Medical Ingenuities
345 Browning Court
Wheaton, IL 60189 US
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Contact Richard "Chip" Corrigan
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Regulation Number 870.4450

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Classification Product Code DXC
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Date Received 06/22/2020
Decision Date 10/30/2020
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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