Home / 510(k) Clearances / K984058

510(k) K984058

ACIST INJECTOR SYSTEM, MODEL CL100 H by Acist Medical Systems — Product Code IZQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 11, 1999
Date Received
November 13, 1998
Clearance Type
Traditional
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 Acist Medical Systems

  • K233904 — ACIST RXi System (016616); ACIST Navvus II Catheter (016675_ (July 17, 2024)
  • K203004 — ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System (December 17, 2020)
  • K193183 — ACIST HDi System, ACIST Kodama Intravascular Ultrasound Catheter (March 20, 2020)
  • K190473 — ACIST RXi System and Navvus II Catheter (September 13, 2019)
  • K191060 — ACIST CVI1 Contrast Delivery System, A1000 Syringe Kit, A1000V Syringe Kit, BT20 (July 18, 2019)
  • K191175 — ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System (June 27, 2019)
  • K171646 — ACISTCVi® Contrast Delivery System (February 16, 2018)
  • K173063 — ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System (October 23, 2017)
  • K172216 — ACIST RXi Mini System (August 18, 2017)
  • K132474 — CARDIOVASCULAR PRESSURE MEASUREMENT (CPM) SYSTEM, NAVVUS CATHETER (January 30, 2014)

Other clearances for product code IZQ

  • K252281 — ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheas (November 18, 2025)
  • 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)