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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 K182972
Device Name Phoenix Atherectomy System
Applicant
Volcano Atheromed, Inc.
1530 O'Brien Dr.
Suite A
Menlo Park,  CA  94025
Applicant Contact Jean Chang
Correspondent
Volcano Atheromed, Inc.
1530 O'Brien Dr.
Suite A
Menlo Park,  CA  94025
Correspondent Contact Jean Chang
Regulation Number870.4875
Classification Product Code
MCW  
Date Received10/26/2018
Decision Date 12/20/2018
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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