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510(k) K220544

DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA Catheter model 2.0) by Ra Medical Systems,Inc — Product Code PDU

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 29, 2022
Date Received
February 25, 2022
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 Ra Medical Systems,Inc

  • K210664 — DABRA Laser System (DABRA Laser model RA-308 and DABRA Catheter model 101) (July 27, 2021)
  • K170349 — RA-308 Excimer Laser System, Excimer Laser Catheter (May 24, 2017)
  • K062963 — PHAROS EXCIMER LASER SYSTEM, MODEL EX-308 (April 3, 2007)

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