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510(k) K120892

DISPOSABLE 330PSI EXTENSION LINES by Coeur, Inc. — Product Code DXT

K120892 is an FDA 510(k) premarket notification submitted by Coeur, Inc. for the device "DISPOSABLE 330PSI EXTENSION LINES". The FDA issued a decision of Substantially Equivalent on June 10, 2013. The device falls under product code DXT (Injector And Syringe, Angiographic), a Class II device regulated under 21 CFR 870.1650. Coeur, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 10, 2013
Date Received
March 23, 2012
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.

  • K170431 — CT Syringe for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tu (August 18, 2017)
  • 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)
  • 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

  • K252652 — Disposable Syringes with Accessories for Power Injectors (900103T); Disposable S (May 14, 2026)
  • K252653 — ACIST Pro Diagnostic System (019304); Processing Unit Bed Mount; AngioTouch Modu (May 13, 2026)
  • K252638 — VeraPro S100 Multi-Use Syringe (018808); VeraPro S100 LV1 Low Viscosity Single-U (May 13, 2026)
  • K253048 — High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfe (April 16, 2026)
  • 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)

FDA data resources