FDA 510(k) Application Details - K994141

Device Classification Name Catheter, Intravascular Occluding, Temporary

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510(K) Number K994141
Device Name Catheter, Intravascular Occluding, Temporary
Applicant MEDTRONIC AVE, INC.
3576 UNOCAL PL.
SANTA ROSA, CA 95403 US
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Contact SHELLY TRIMM
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Regulation Number 870.4450

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Classification Product Code MJN
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Date Received 12/08/1999
Decision Date 07/21/2000
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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