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510(k) K251158

PowerWire® 14 Radiofrequency Guidewire Kit by Baylis Medical Technologies, Inc. — Product Code PDU

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
September 11, 2025
Date Received
April 15, 2025
Clearance Type
Traditional
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 Baylis Medical Technologies, Inc.

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  • K250275 — PrecisePath™ Radiofrequency Puncture Generator and PrecisePath™ Footswitch (October 28, 2025)
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  • K230571 — RFP-100A Connector Cable (Single Use) (May 30, 2023)

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  • K230159 — SoundBite® Crossing System XS Peripheral (August 28, 2023)
  • K230594 — Tigereye ST CTO-Crossing Catheter (April 25, 2023)
  • K221163 — Tunnel Crossing Catheter (January 19, 2023)
  • K221541 — LimFlow ARC (August 31, 2022)
  • K220544 — DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA Catheter model 2. (June 29, 2022)
  • K211802 — GoBack Crossing Catheter (March 1, 2022)
  • K212468 — Tigereye CTO-Crossing Catheter (January 6, 2022)