FDA 510(k) Application Details - K974473

Device Classification Name Catheter, Continuous Flush

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510(K) Number K974473
Device Name Catheter, Continuous Flush
Applicant MICRO THERAPEUTICS, INC.
1062-F CALLE NEGOCIO
SAN CLEMENTE, CA 92673 US
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Contact TOM DAUGHTERS
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Regulation Number 870.1210

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Classification Product Code KRA
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Date Received 11/26/1997
Decision Date 06/17/1998
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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