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510(k) K232536

Soldier Microcatheter by Embolx, Inc. — Product Code DQO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 23, 2024
Date Received
August 21, 2023
Clearance Type
Traditional
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 Embolx, Inc.

  • K180904 — Sniper Infusion Catheter with Balloon Occlusion (June 8, 2018)
  • K142692 — Occlusion Balloon Catheter (May 31, 2015)

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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)
  • K221279 — pNOVUS 21 Microcatheter (November 28, 2022)