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510(k) K252653

ACIST Pro Diagnostic System (019304); Processing Unit Bed Mount; AngioTouch Module; ACIST Pro Cart; Single Transducer Cable; Triple Transducer Cable by Acist Medical Systems, Inc. — Product Code DXT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 13, 2026
Date Received
August 22, 2025
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 Acist Medical Systems, Inc.

  • K252638 — VeraPro S100 Multi-Use Syringe (018808); VeraPro S100 LV1 Low Viscosity Single-U (May 13, 2026)
  • 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)

Other clearances for product code DXT

  • K252652 — Disposable Syringes with Accessories for Power Injectors (900103T); Disposable S (May 14, 2026)
  • K252638 — VeraPro S100 Multi-Use Syringe (018808); VeraPro S100 LV1 Low Viscosity Single-U (May 13, 2026)
  • K253048 — High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfe (April 16, 2026)
  • 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)