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510(k) K163376

Mikro-Cath Pressure Catheter by Millar, Inc. — Product Code DXO

K163376 is an FDA 510(k) premarket notification submitted by Millar, Inc. for the device "Mikro-Cath Pressure Catheter". The FDA issued a decision of Substantially Equivalent on March 10, 2017. 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
March 10, 2017
Date Received
December 1, 2016
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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  • 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)
  • K190852 — Zurich Pressure Guidewire System Model 100 (August 14, 2019)
  • K183413 — TruWave Disposable Pressure Transducer (May 1, 2019)

FDA data resources