Extension Line

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

510(k) Number

K800622 ↗

FDA Product Code

DQO

Device Class

Class II

Regulation

21 CFR Part 870.1200

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Stopcock, Three Way

  Class II

  FDA 510(k) K791107 Active Cleared 22 Jun 1979

• Tygon Pac-Stopcocks

  Class II

  FDA 510(k) K770708 Active Cleared 8 Jun 1977

• Norton Manifold

  Class II

  FDA 510(k) K820864 Active Cleared 15 Apr 1982

• Tygon Pac-Monitoring Lines & Fluid Admin

  Class II

  FDA 510(k) K770916 Active Cleared 17 Jun 1977

• Percutaneous Catheter Introducer Adapter

  Class II

  FDA 510(k) K800621 Active Cleared 24 Apr 1980

• Venous M/a Internal Jugular Kit

  Class II

  FDA 510(k) K800620 Active Cleared 24 Apr 1980

See all devices from Norton Performance Plastics Corp. →

• What is the Extension Line used for?

  The Extension Line is a catheter, intravascular, diagnostic device designed for cardiovascular applications. It serves as a component to extend the reach of intravascular catheter systems in clinical settings.

• How is the Extension Line supplied?

  The Extension Line is supplied as a component for use in clinical settings, intended to be connected to intravascular catheters to extend their reach during procedures.

• What is the regulatory status of the Extension Line?

  The Extension Line is regulated as a Class II medical device with special controls. It received FDA 510(k) clearance under K800622 on April 29, 1980, based on substantial equivalence to a predicate device.

• Is the Extension Line single-use or reusable?

  The device data does not specify whether the Extension Line is single-use or reusable. This information would typically be found in the product's instructions for use or labeling.