Home / 510(k) Clearances / K190852

510(k) K190852

Zurich Pressure Guidewire System Model 100 by Zurich Medical, Inc. — Product Code DXO

K190852 is an FDA 510(k) premarket notification submitted by Zurich Medical, Inc. for the device "Zurich Pressure Guidewire System Model 100". The FDA issued a decision of Substantially Equivalent on August 14, 2019. The device falls under product code DXO (Transducer, Pressure, Catheter Tip), a Class II device regulated under 21 CFR 870.2870.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 14, 2019
Date Received
April 2, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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

Other clearances for product code DXO

  • K251367 — OptoMonitor 3 (January 16, 2026)
  • K241418 — OptoMonitor 3 (February 12, 2025)
  • K233904 — ACIST RXi System (016616); ACIST Navvus II Catheter (016675_ (July 17, 2024)
  • 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)
  • K183413 — TruWave Disposable Pressure Transducer (May 1, 2019)
  • K180558 — PressureWire X (March 28, 2018)

FDA data resources