FDA 510(k) Application Details - K211476

Device Classification Name Catheter, Thrombus Retriever

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510(K) Number K211476
Device Name Catheter, Thrombus Retriever
Applicant Imperative Care Inc.
1359 Dell Avenue
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 05/12/2021
Decision Date 06/08/2021
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



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