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510(k) K063503

OPTIVANTAGE DH INJECTOR SYSTEM WITH ENHANCED COMMUNICATION by Mallinckrodt Inc., Liebel-Flarsheim Business — Product Code IZQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 27, 2007
Date Received
November 20, 2006
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Injector, Contrast Medium, Automatic
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)
  • K042744 — OPTIV ANTAGE DH POWER INJECTION SYSTEM (November 30, 2004)
  • 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)

Other clearances for product code IZQ

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  • K251295 — ulrichINJECT CT Motion (XD 8000) (November 7, 2025)
  • K252689 — MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Pa (September 24, 2025)
  • K241849 — MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Pa (November 5, 2024)
  • K241850 — ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheas (August 26, 2024)
  • K233737 — ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheas (April 19, 2024)
  • K210541 — ulrichINJECT CT motion (August 6, 2021)
  • K192872 — ulrichINJECT CT Motion (July 2, 2020)
  • K171392 — ulrichINJECT CT motion (November 9, 2017)
  • K151048 — CT Expres 3D Contrast Media Delivery System, Bottle Spike Type B, Day Set III HP (January 22, 2016)