Home / 510(k) Clearances / K170431

510(k) K170431

CT Syringe for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tubes), CT Syringe Dual Pack for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tubes), Single Fascia and Ram Tip, Dual Fascia and Ram Tip by Coeur, Inc. — Product Code DXT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 18, 2017
Date Received
February 13, 2017
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 Coeur, Inc.

  • K161471 — MR Syringe Dual Pack for Solaris Injectors (October 6, 2016)
  • K150902 — 330psi Extension Y-Line with Dual Check Valve (October 22, 2015)
  • K142745 — 125mL CT Syringe (April 1, 2015)
  • K140469 — MR SYRINGE DUAL PACK (July 28, 2014)
  • K133600 — COEUR, INC. FRONTLOAD FOR OPTIVANTAGE POWER INJECTOR (April 30, 2014)
  • K120892 — DISPOSABLE 330PSI EXTENSION LINES (June 10, 2013)
  • K113498 — DISPOSABLE TORQUE DEVICE (July 20, 2012)
  • K113132 — DISPOSABLE HEMOSTATIC Y-CONNECTORS (January 20, 2012)
  • K090487 — DISPOSABLE ANGIOGRAPHIC SYRINGES FOR USE WITH NEMOTO ANGIOGRAPHIC POWER, MODEL S (October 19, 2009)
  • K070798 — ADAPTERS FOR CT, ANGIOGRAPHIC, AND/OR MRI POWER INJECTORS (October 4, 2007)

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)
  • 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)