FDA 510(k) Application Details - K233988

Device Classification Name Catheter, Thrombus Retriever

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510(K) Number K233988
Device Name Catheter, Thrombus Retriever
Applicant Cerenovus, Inc.
6303 Waterford District Drive, Suites 215 & 315
Miami, FL 33216 US
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Contact Ryan Rivera
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Regulation Number 870.1250

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Classification Product Code NRY
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Date Received 12/18/2023
Decision Date 01/17/2024
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review

FDA Source Information for K233988


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