Concord/PorteX Epidural Catheters

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K935927 ↗

FDA Product Code

BSO

Device Class

Class II

Regulation

21 CFR Part 868.5120

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Percutaneous Tracheostomy Kit

  Class II

  FDA 510(k) K936133 Active Cleared 23 Mar 1994

• Pro-Vent(Tm), Pulsator(R), and Line Draw(Tm) Arterial Blood Sampling Syringes

  Class II

  FDA 510(k) K945777 Active Cleared 22 Dec 1994

• Sims Cpap System

  Class II

  FDA 510(k) K953485 Active Cleared 26 Oct 1995

• Regional Anesthesia Trays Open recall

  Class II

  FDA 510(k) K965017 Active Cleared 14 Mar 1997

• Fenestrated Flexible D.I.C. Tracheostomy Tube Cuffed

  Class II

  FDA 510(k) K972385 Active Cleared 20 Jan 1998

• Pro-Vent, Line Draw, Pulsator Open recall

  Class II

  FDA 510(k) K952516 Active Cleared 14 Jul 1995

See all devices from Smiths Industries Medical Systems, Inc. →

• What is the Concord/PorteX Epidural Catheter used for?

  The Concord/PorteX Epidural Catheter is an anesthesia conduction catheter designed to inject local anesthetics into a patient and provide continuous regional anesthesia, specifically for use in anesthesiology procedures.

• Is the Concord/PorteX Epidural Catheter sterile or non-sterile, and is it intended for single use or reuse?

  The Concord/PorteX Epidural Catheter is supplied non-sterile and is intended for single use only, meaning it should not be reprocessed or reused after initial patient contact to ensure safety and performance.

• How was the Concord/PorteX Epidural Catheter cleared for market, and what is its regulatory classification?

  The Concord/PorteX Epidural Catheter was cleared via the FDA 510(k) pathway under submission K935927 on September 9, 1994, and is classified as a Class II medical device under regulation number 868.5120.