FDA 510(k) Application Details - K200206

Device Classification Name

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510(K) Number K200206
Device Name AXS Vecta 71 Intermediate Catheter, AXS Vecta 74 Intermediate Catheter
Applicant Stryker Neurovascular
47900 Bayside Parkway
Fremont, CA 94538 US
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Contact Shazia Hakim
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Regulation Number

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Classification Product Code QJP
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Date Received 01/28/2020
Decision Date 02/27/2020
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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