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510(k) K192657

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 7, 2020
Date Received
September 25, 2019
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.

  • K241109 — Single-use Sterile High-pressure Angiographic Syringes and Accessories (August 22, 2024)
  • K211564 — Sterile High-pressure Angiographic Syringes for Single-use (October 19, 2021)

Other clearances for product code DXT

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  • K242143 — Angiography Injector (December 23, 2024)
  • K242212 — Disposable Syringe (Kit); Nemoto Disposable Syringe (Kit) (August 27, 2024)
  • K241109 — Single-use Sterile High-pressure Angiographic Syringes and Accessories (August 22, 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)