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510(k) K242212

Disposable Syringe (Kit); Nemoto Disposable Syringe (Kit) by Nemoto Kyorindo Co., Ltd. — Product Code DXT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 27, 2024
Date Received
July 29, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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

Other clearances by Nemoto Kyorindo Co., Ltd.

  • K173450 — PRESS DUO elite, PRESS DUO elite AG (February 7, 2018)
  • K133189 — DUAL SHOT ALPHA 7 (June 30, 2014)
  • K092896 — REMPRESS AND ANGIOGRAPHY CONTRAST DELIVERY SYSTEM REMPRESS (October 29, 2010)
  • K091734 — SONIC SHOT GX (May 21, 2010)
  • K071691 — DUAL SHOT ALPHA (December 19, 2007)
  • K062168 — CONTRAST DELIVERY SYSTEM - DUAL SHOT ALPHA (August 18, 2006)
  • K052633 — DUAL SHOT - CONTRAST DELIVERY SYSTEM (October 17, 2005)

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  • K242143 — Angiography Injector (December 23, 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)
  • K201395 — Sterile High-pressure Angiographic Syringes for single-use (October 28, 2020)