FDA 510(k) Application Details - K142261

Device Classification Name Catheter, Angioplasty, Peripheral, Transluminal

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510(K) Number K142261
Device Name Catheter, Angioplasty, Peripheral, Transluminal
Applicant Bard Peripheral Vascular, Inc.
1625 West Third Street
Tempe, AZ 85281 US
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Contact Mario Thomas
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Regulation Number 870.1250

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Classification Product Code LIT
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Date Received 08/14/2014
Decision Date 09/24/2014
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 Y
Expedited Review



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