Home / 510(k) Clearances / K935166

510(k) K935166

FLOW DIRECTED MIKRO-TIP PRESSURE TRANSDUCER by Millar Instruments, Inc. — Product Code DXO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 5, 1994
Date Received
October 27, 1993
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 Millar Instruments, Inc.

  • K112323 — CARDIA-CATH (October 18, 2011)
  • K093111 — MIKRO-CATH, MODEL 825-0101 (January 5, 2010)
  • K013205 — MILLAR PRESSURE CONTROL UNIT MODEL PCU-2000 (July 2, 2002)
  • K993694 — MIKRO-TIP ANGIOGRAPHIC CATHETER (March 1, 2000)
  • K952773 — MIKRO-TIP ANGIOGRAPHIC CATHETER (November 7, 1995)
  • K915775 — MILLAR NONMAGNECTIC MIKRO-TIP CATHETER PRESS. TRAN (April 20, 1992)
  • K896264 — MILLAR MIKRO-TIP DOPPLER CATHETER (January 24, 1990)
  • K895721 — MILLAR MIKRO-TIP PULSE TRANSDUCER (December 7, 1989)
  • K883651 — MILLAR MIKRO-TIP CATHETER PRESSURE TRANSDUCER (November 18, 1988)
  • K860766 — MILLAR PULSED DOPPLER VELOCIMETER (July 29, 1986)

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)
  • K190852 — Zurich Pressure Guidewire System Model 100 (August 14, 2019)
  • K183413 — TruWave Disposable Pressure Transducer (May 1, 2019)