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510(k) K242947

FreedomFlow™ Orbital Circumferential Atherectomy System by Cardio Flow Inc., — Product Code MCW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 5, 2024
Date Received
September 25, 2024
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 Cardio Flow Inc.,

  • K250723 — FreedomFlow™ Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere Con (April 25, 2025)
  • K233483 — FreedomFlow Orbital Circumferential Atherectomy System (H6004/5Fr 3-Sphere Confi (February 15, 2024)
  • K231538 — FreedomFlow Orbital Circumferential Atherectomy System (September 27, 2023)
  • K213834 — Cardio Flow Peripheral Guide Wire (March 18, 2022)

Other clearances for product code MCW

  • K250723 — FreedomFlow™ Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere Con (April 25, 2025)
  • K250385 — Turbo-Elite Laser Atherectomy Catheter (March 13, 2025)
  • K242757 — Rotarex Atherectomy System (January 30, 2025)
  • K241553 — Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophili (June 27, 2024)
  • K233483 — FreedomFlow Orbital Circumferential Atherectomy System (H6004/5Fr 3-Sphere Confi (February 15, 2024)
  • 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)
  • K222837 — Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Ather (December 8, 2022)