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510(k) K211518

2.4mm X 130cm Phoenix Deflecting Atherectomy System, 1.5mm X 149cm Phoenix Atherectomy System by Volcano Atheromed, Inc. — Product Code MCW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 14, 2021
Date Received
May 17, 2021
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.

  • K193197 — QuickClear Mechanical Thrombectomy System (April 20, 2020)
  • K182972 — Phoenix Atherectomy System (December 20, 2018)
  • 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)
  • 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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