Home / 510(k) Clearances / K193647

510(k) K193647

Superpipe Angiographic Catheter by Suzhou Hengrui Disheng Medical Co., Ltd. — Product Code DQO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 29, 2020
Date Received
December 30, 2019
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 Suzhou Hengrui Disheng Medical Co., Ltd.

  • K193653 — Hydrophilic Coating Guide Wire (August 26, 2020)
  • K171665 — Microcatheter and guide-wire system (January 11, 2018)

Other clearances for product code DQO

  • K254278 — Arterial Pressure Monitoring Set/Tray (March 25, 2026)
  • K250751 — DualView Catheter (July 17, 2025)
  • K242966 — Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter (January 31, 2025)
  • K242420 — pNOVUS 21 Microcatheter (November 12, 2024)
  • K233268 — Impress Angiographic Catheter (May 22, 2024)
  • K233975 — Zoom 6F Insert Catheters (April 2, 2024)
  • K232536 — Soldier Microcatheter (February 23, 2024)
  • K232573 — INFINITI™ Ambi Angiographic Catheter (November 21, 2023)
  • K230620 — Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter (August 8, 2023)
  • K231293 — Drakon™ and Sequre® Microcatheters (June 1, 2023)