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510(k) K203487

Drakon and Sequre Microcatheters by Accurate Medical Therapeutics, Ltd. — Product Code DQO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 11, 2020
Date Received
November 27, 2020
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Diagnostic
Device Class
Class II
Regulation Number
870.1200
Review Panel
CV
Submission Type

Other clearances by Accurate Medical Therapeutics, Ltd.

  • K231293 — Drakon™ and Sequre® Microcatheters (June 1, 2023)
  • K202797 — Drakon and Sequre Microcatheters (October 23, 2020)
  • K173430 — SeQure® NF and SeQure® Microcatheters (January 26, 2018)

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  • K232536 — Soldier Microcatheter (February 23, 2024)
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  • K230620 — Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter (August 8, 2023)
  • K231293 — Drakon™ and Sequre® Microcatheters (June 1, 2023)
  • K230411 — Dragonfly OpStar™ Imaging Catheter (April 14, 2023)