FST Disposable Fiber Optic Transducer #0100-00

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K864000 ↗

FDA Product Code

DXO

Device Class

Class II

Regulation

21 CFR Part 870.2870

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Fst Cath-Ud, Catheter

  Class II

  FDA 510(k) K950908 Active Cleared 7 Apr 1995

• Uro-Pro 2000

  Class II

  FDA 510(k) K922476 Active Cleared 20 Jul 1993

• Fst Cath Ud-Dual Dual Pressure Catheter

  Class II

  FDA 510(k) K926088 Active Cleared 18 Jun 1993

• Fst Cath - Ui Usrodynamic Cath Introducer System

  Class II

  FDA 510(k) K913721 Active Cleared 8 Oct 1991

• 4-Channel Urodynamic Monitor with Uro-Flo Option

  Class II

  FDA 510(k) K945495 Active Cleared 9 Feb 1995

• Fst Cath-Ud Catheter, Modification

  Class II

  FDA 510(k) K913113 Active Cleared 9 Oct 1991

See all devices from Fiberoptic Sensor Technlogies, Inc. →

• What is the FST Disposable Fiber Optic Transducer #0100-00 used for?

  The FST Disposable Fiber Optic Transducer #0100-00 is designed for catheter tip applications to convert pressure measurements into optical signals for monitoring cardiovascular conditions. It is specifically intended for use in cardiovascular procedures.

• Is the FST Disposable Fiber Optic Transducer reusable or single-use?

  The FST Disposable Fiber Optic Transducer #0100-00 is supplied as a disposable product and is not intended for reuse. Each unit should be used only once and then discarded according to medical waste disposal protocols.

• What is the regulatory classification of this transducer?

  The FST Disposable Fiber Optic Transducer #0100-00 is classified as a Class II medical device with FDA 510(k) clearance under product code DXO. It has been authorized for use in cardiovascular procedures with the specific clearance number K864000.

• How is the FST Disposable Fiber Optic Transducer supplied?

  The FST Disposable Fiber Optic Transducer #0100-00 is supplied as a disposable product ready for single-use in catheter tip applications. It is manufactured by Fiberoptic Sensor Technologies, Inc. and comes pre-sterilized for immediate use in cardiovascular monitoring procedures.