FDA 510(k) Application Details - K133043

Device Classification Name Catheter, Angioplasty, Peripheral, Transluminal

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510(K) Number K133043
Device Name Catheter, Angioplasty, Peripheral, Transluminal
Applicant ANGIOSLIDE, LTD
11925 W I-70 FRONTAGE RAOD NORTH
WHEAT RIDGE, CO 80033 US
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Contact CLAY ANSELMO
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Regulation Number 870.1250

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Classification Product Code LIT
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Date Received 09/26/2013
Decision Date 12/06/2013
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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