FDA 510(k) Application Details - K191768

Device Classification Name Catheter, Thrombus Retriever

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510(K) Number K191768
Device Name Catheter, Thrombus Retriever
Applicant Stryker Neurovascular
47900 Bayside Parkway
Fremont, CA 94538 US
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Contact Shazia Hakim
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Regulation Number 870.1250

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Classification Product Code NRY
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Date Received 07/01/2019
Decision Date 07/30/2019
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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