FDA 510(k) Application Details - K052038

Device Classification Name Catheter, Angioplasty, Peripheral, Transluminal

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510(K) Number K052038
Device Name Catheter, Angioplasty, Peripheral, Transluminal
Applicant Boston Scientific Corporation
3574 RUFFIN ROAD
SAN DIEGO, CA 92123 US
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Contact RENUKA KRISHNAN
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Regulation Number 870.1250

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Classification Product Code LIT
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Date Received 07/28/2005
Decision Date 08/16/2005
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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