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510(k) K181877

Phoenix 2.4mm Atherectomy Plus System by Volcano Atheromed, Inc. — Product Code MCW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 2018
Date Received
July 13, 2018
Clearance Type
Traditional
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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  • K182972 — Phoenix Atherectomy System (December 20, 2018)
  • K172386 — 1.8mm X 149cm Phoenix Atherectomy System, 2.2mm X 149cm Phoenix Atherectomy Syst (August 24, 2017)
  • K151145 — 2.4mm X 127 cm Phoenix Atherectomy Deflecting System (May 26, 2015)
  • K143328 — 1.8mm X 149 cm Phoenix Atherectomy Catheter, 2.2mm X 149 cm Phoenix Atherectomy (December 19, 2014)

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