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510(k) K251376

LimFlow ARC by LimFlow, Inc. — Product Code PDU

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 31, 2025
Date Received
May 2, 2025
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter For Crossing Total Occlusions
Device Class
Class II
Regulation Number
870.1250
Review Panel
CV
Submission Type

To facilitate the intraluminal placement of conventional guidewires beyond stenotic lesions (including subchronic and chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention, such as angioplasty, atherectomy or stent placement.

Other clearances by LimFlow, Inc.

  • K242776 — LimFlow V-Ceiver (February 14, 2025)
  • K221902 — LimFlow Vector (December 21, 2022)
  • K221541 — LimFlow ARC (August 31, 2022)
  • K222083 — LimFlow V-Ceiver (August 9, 2022)

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  • K221163 — Tunnel Crossing Catheter (January 19, 2023)
  • K221541 — LimFlow ARC (August 31, 2022)
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