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510(k) K250723

FreedomFlow™ Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere Configuration) by Cardio Flow Inc., — Product Code MCW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 25, 2025
Date Received
March 10, 2025
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.,

  • K242947 — FreedomFlow™ Orbital Circumferential Atherectomy System (November 5, 2024)
  • 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

  • K250385 — Turbo-Elite Laser Atherectomy Catheter (March 13, 2025)
  • K242757 — Rotarex Atherectomy System (January 30, 2025)
  • K242947 — FreedomFlow™ Orbital Circumferential Atherectomy System (November 5, 2024)
  • 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)