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510(k) K151145

2.4mm X 127 cm Phoenix Atherectomy Deflecting System by Volcano Atheromed, Inc. — Product Code MCW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 26, 2015
Date Received
April 29, 2015
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Peripheral, Atherectomy
Device Class
Class II
Regulation Number
870.4875
Review Panel
CV
Submission Type

Other clearances by Volcano Atheromed, Inc.

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  • K181877 — Phoenix 2.4mm Atherectomy Plus System (December 17, 2018)
  • K172386 — 1.8mm X 149cm Phoenix Atherectomy System, 2.2mm X 149cm Phoenix Atherectomy Syst (August 24, 2017)
  • K143328 — 1.8mm X 149 cm Phoenix Atherectomy Catheter, 2.2mm X 149 cm Phoenix Atherectomy (December 19, 2014)

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