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510(k) K984088

OPTISTAR MR INJECTOR SYSTEM by Mallinckrodt Inc., Liebel-Flarsheim Business — Product Code DXT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 6, 1999
Date Received
November 16, 1998
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 Mallinckrodt Inc., Liebel-Flarsheim Business

  • K082212 — SYRINGE WITH HANDI-FIL (January 22, 2009)
  • K073592 — OPTISTAR ELITE INJECTION SYSTEM (May 7, 2008)
  • K063503 — OPTIVANTAGE DH INJECTOR SYSTEM WITH ENHANCED COMMUNICATION (April 27, 2007)
  • K042744 — OPTIV ANTAGE DH POWER INJECTION SYSTEM (November 30, 2004)
  • K031339 — OPTIBOLUS (July 11, 2003)
  • K022116 — ELPH INJECTION SYSTEM (July 26, 2002)
  • K963071 — ANGIOMAT ILLUMENA (September 23, 1997)

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)