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510(k) K042744

OPTIV ANTAGE DH POWER INJECTION SYSTEM by Mallinckrodt Inc., Liebel-Flarsheim Business — Product Code DXT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 30, 2004
Date Received
October 4, 2004
Clearance Type
Special
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)
  • K031339 — OPTIBOLUS (July 11, 2003)
  • K022116 — ELPH INJECTION SYSTEM (July 26, 2002)
  • K984088 — OPTISTAR MR INJECTOR SYSTEM (December 6, 1999)
  • K963071 — ANGIOMAT ILLUMENA (September 23, 1997)

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  • 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)