FDA 510(k) Application Details - K173762

Device Classification Name Catheter, Intravascular, Diagnostic

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510(K) Number K173762
Device Name Catheter, Intravascular, Diagnostic
Applicant AngioDynamics, Inc.
603 Queensbury Avenue
Queensbury, NY 12804 US
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Contact Teri Juckett
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Regulation Number 870.1200

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Classification Product Code DQO
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Date Received 12/11/2017
Decision Date 07/18/2018
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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