FDA 510(k) Application Details - K170987

Device Classification Name Device, Percutaneous Retrieval

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510(K) Number K170987
Device Name Device, Percutaneous Retrieval
Applicant Avantec Vascular Corporation
605 W. California Avenue
Sunnyvale, CA 94086 US
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Contact Nicholas deBeer
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Regulation Number 870.5150

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Classification Product Code MMX
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Date Received 04/03/2017
Decision Date 08/28/2017
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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