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510(k) K181642

B-Laser Atherectomy System by Eximo Medical, Ltd. — Product Code MCW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 5, 2018
Date Received
June 21, 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

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  • 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)
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  • K230005 — Pantheris LV Atherectomy Catheter (June 6, 2023)