FDA 510(k) Application Details - K020634

Device Classification Name Catheter, Embolectomy

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510(K) Number K020634
Device Name Catheter, Embolectomy
Applicant ATRIUM MEDICAL CORP.
5 WENTWORTH DR.
HUDSON, NH 03051 US
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Contact JOSEPH P DE PAOLA
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Regulation Number 870.5150

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Classification Product Code DXE
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Date Received 02/27/2002
Decision Date 05/08/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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