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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 K140944
Device Name 1.8 MM PHOENIX ATHERECTOMY CATHETER, 2.2 MM PHOENIX ATHERECTOMY CATHETER, PHOENIX HANDLE, PHOENIX WIRE SUPPORT CLIP
Applicant
Atheromed, Inc.
1455 Adams Dr., Suite 1120
Menlo Park,  CA  94025
Applicant Contact JEAN CHANG
Correspondent
Atheromed, Inc.
1455 Adams Dr., Suite 1120
Menlo Park,  CA  94025
Correspondent Contact JEAN CHANG
Regulation Number870.4875
Classification Product Code
MCW  
Date Received04/14/2014
Decision Date 08/22/2014
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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