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510(k) K190473

ACIST RXi System and Navvus II Catheter by Acist Medical Systems, Inc. — Product Code OBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 13, 2019
Date Received
February 27, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Pressure Monitoring, Cardiac
Device Class
Class II
Regulation Number
870.1200
Review Panel
CV
Submission Type

To measure pressure within the cardiovascular system.

Other clearances by Acist Medical Systems, Inc.

  • 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)
  • 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)