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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Peripheral, Atherectomy
510(k) Number K143328
Device Name 1.8mm X 149 cm Phoenix Atherectomy Catheter, 2.2mm X 149 cm Phoenix Atherectomy Catheter, Phoenix Handle, Phoenix Wire Support Clip
Applicant
Volcano Atheromed, Inc.
1455 Adams Dr., Suite 1120
Menlo Park,  CA  94025
Applicant Contact Jean Chang
Correspondent
Volcano Atheromed, Inc.
1455 Adams Dr., Suite 1120
Menlo Park,  CA  94025
Correspondent Contact Jean Chang
Regulation Number870.4875
Classification Product Code
MCW  
Date Received11/20/2014
Decision Date 12/19/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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