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510(k) K182972

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 2018
Date Received
October 26, 2018
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.

  • K211518 — 2.4mm X 130cm Phoenix Deflecting Atherectomy System, 1.5mm X 149cm Phoenix Ather (June 14, 2021)
  • K193197 — QuickClear Mechanical Thrombectomy System (April 20, 2020)
  • 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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  • K233668 — Auryon Atherectomy Catheter 1.5 mm XL, Hydrophilic Coating (EXM-4010-H000), Aury (December 15, 2023)
  • K231538 — FreedomFlow Orbital Circumferential Atherectomy System (September 27, 2023)
  • K230709 — Auryon Atherectomy System (June 9, 2023)
  • K230005 — Pantheris LV Atherectomy Catheter (June 6, 2023)