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510(k) K210664

DABRA Laser System (DABRA Laser model RA-308 and DABRA Catheter model 101) by Ra Medical Systems,Inc — Product Code PDU

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 2021
Date Received
March 5, 2021
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

  • K220544 — DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA Catheter model 2. (June 29, 2022)
  • 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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  • 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)