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510(k) K233904

ACIST RXi System (016616); ACIST Navvus II Catheter (016675_ by Acist Medical Systems, Inc. — Product Code DXO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 17, 2024
Date Received
December 11, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transducer, Pressure, Catheter Tip
Device Class
Class II
Regulation Number
870.2870
Review Panel
CV
Submission Type

Other clearances by Acist Medical Systems, Inc.

  • 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)
  • K093657 — ADAGIO RETRACTING ECG LEAD WIRES (January 15, 2010)

Other clearances for product code DXO

  • K251367 — OptoMonitor 3 (January 16, 2026)
  • K241418 — OptoMonitor 3 (February 12, 2025)
  • K222216 — TruWave Disposable Pressure Transducer (December 22, 2022)
  • K202943 — OptoMonitor 3 (November 24, 2020)
  • K193620 — OptoMonitor 3 (June 18, 2020)
  • K193279 — Comet II Pressure Guidewire (December 23, 2019)
  • K192340 — OptoMonitor (December 12, 2019)
  • K190852 — Zurich Pressure Guidewire System Model 100 (August 14, 2019)
  • K183413 — TruWave Disposable Pressure Transducer (May 1, 2019)
  • K180558 — PressureWire X (March 28, 2018)