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510(k) K241109

Single-use Sterile High-pressure Angiographic Syringes and Accessories by Shenzhen Boon Medical Supply Co., Ltd. — Product Code DXT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 22, 2024
Date Received
April 22, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Injector And Syringe, Angiographic
Device Class
Class II
Regulation Number
870.1650
Review Panel
HO
Submission Type

Other clearances by Shenzhen Boon Medical Supply Co., Ltd.

  • K211564 — Sterile High-pressure Angiographic Syringes for Single-use (October 19, 2021)
  • K192657 — Sterile High-pressure Angiographic Syringes for Single-use (August 7, 2020)

Other clearances for product code DXT

  • K251788 — Extension tube (March 5, 2026)
  • K252891 — MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD (February 13, 2026)
  • K244038 — High Pressure Tubing (September 5, 2025)
  • K242143 — Angiography Injector (December 23, 2024)
  • K242212 — Disposable Syringe (Kit); Nemoto Disposable Syringe (Kit) (August 27, 2024)
  • K230668 — Disposable High-pressure Extension Lines (June 14, 2024)
  • K232388 — High Pressure Tubing (November 21, 2023)
  • K211564 — Sterile High-pressure Angiographic Syringes for Single-use (October 19, 2021)
  • K203004 — ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System (December 17, 2020)
  • K201395 — Sterile High-pressure Angiographic Syringes for single-use (October 28, 2020)