FDA 510(k) Application Details - K954020

Device Classification Name Catheter, Continuous Flush

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510(K) Number K954020
Device Name Catheter, Continuous Flush
Applicant MICRO THERAPEUTICS, INC.
27412-B LAGUNA HILLS DR.
ALISO VIEJO, CA 92656 US
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Contact LINDA D'ABATE
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Regulation Number 870.1210

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Classification Product Code KRA
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Date Received 07/28/1995
Decision Date 01/02/1996
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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