FDA 510(k) Application Details - K242672

Device Classification Name Catheter, Thrombus Retriever

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510(K) Number K242672
Device Name Catheter, Thrombus Retriever
Applicant Imperative Care, Inc.
1359 Dell Ave
Campbell, CA 95008 US
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Contact Teri Nguyen
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Regulation Number 870.1250

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Classification Product Code NRY
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Date Received 09/06/2024
Decision Date 01/14/2025
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K242672


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