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510(k) K132474

CARDIOVASCULAR PRESSURE MEASUREMENT (CPM) SYSTEM, NAVVUS CATHETER by Acist Medical Systems — Product Code DXO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 2014
Date Received
August 7, 2013
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

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

Other clearances for product code DXO

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  • 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)