FDA Decision Memo and Letters for 510(k) K173352
FDA Decision Memo and Letters for 510(k) K173352
Device Classification Name Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment
510(k) Number K173352
Device Name Trevo Pro Vue Retriever and Trevo XP Pro Vue Retriever (Trevo Retriever)
Applicant Concentric Medical, Inc.
Regulation Number 882.5600
Classification Product Code POL
Subsequent Product Code NRY
Date Received 10/25/2017
Decision Date 02/15/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Clinical Trials NCT02142283
Reviewed by Third Party No
Expedited Review Yes
Combination Product No
Total pages: 74
Fully redacted pages: 40
Content pages: 34
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