FDA 510(k) Application Details - K172494

Device Classification Name Catheter, Angioplasty, Peripheral, Transluminal

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510(K) Number K172494
Device Name Catheter, Angioplasty, Peripheral, Transluminal
Applicant Angioslide, Ltd.
4 Ha'Omanut Street,
Poleg Industrial Area
Netanya 4250438 IL
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Contact Eran Vickus
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Regulation Number 870.1250

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Classification Product Code LIT
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Date Received 08/18/2017
Decision Date 12/15/2017
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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