FDA 510(k) Application Details - K002212

Device Classification Name Wire, Guide, Catheter

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510(K) Number K002212
Device Name Wire, Guide, Catheter
Applicant MICRO THERAPEUTICS, INC.
2 GOODYEAR
IRVINE, CA 92618 US
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Contact MARIBELLE AGUINALDO
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Regulation Number 870.1330

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Classification Product Code DQX
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Date Received 07/21/2000
Decision Date 08/03/2000
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

FDA Source Information for K002212


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