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510(k) K022116

ELPH INJECTION SYSTEM by Mallinckrodt Inc., Liebel-Flarsheim Business — Product Code DXT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 26, 2002
Date Received
July 1, 2002
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

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  • 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)
  • K984088 — OPTISTAR MR INJECTOR SYSTEM (December 6, 1999)
  • K963071 — ANGIOMAT ILLUMENA (September 23, 1997)

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  • K232388 — High Pressure Tubing (November 21, 2023)
  • K211564 — Sterile High-pressure Angiographic Syringes for Single-use (October 19, 2021)
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