FDA 510(k) Application Details - K151317

Device Classification Name Catheter, Angioplasty, Peripheral, Transluminal

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510(K) Number K151317
Device Name Catheter, Angioplasty, Peripheral, Transluminal
Applicant ABBOTT VASCULAR
3200 LAKESIDE DR
SANTA CLARA, CA 95054 US
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Contact Shu Chi Hsu
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Regulation Number 870.1250

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Classification Product Code LIT
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Date Received 05/18/2015
Decision Date 07/06/2015
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



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