FDA 510(k) Application Details - K022003

Device Classification Name Introducer, Catheter

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510(K) Number K022003
Device Name Introducer, Catheter
Applicant MICRO THERAPEUTICS, INC.
2 GOODYEAR
IRVINE, CA 92618 US
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Contact Bill Hyatt
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Regulation Number 870.1340

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Classification Product Code DYB
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Date Received 06/19/2002
Decision Date 09/13/2002
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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