Product Specifications

General Specifications

Description: Designed to be secure to the proximal portion of a guide wire with a
diameter of 0.009”, 0.014” or 0.018”. This device should only be used by
physicians trained in invasive vascular procedures.

Intended use: Vascular procedures in conjunction with interventional and/or
diagnostic devices to facilitate the steering of the guidewire within vascular

Single Use: Not designed to be re-sterilized or reused on another patient.

Sterilization Method: Electron Beam Irradiation, Non-Pyrogenic.

Bore Size: 0.009-0.022”*

Latex Free: Yes

Speed Torque Product Specifications

Speed-Torque Product Comparison

Product Comparison Speed Torque

Regulatory Summary

Establishment Registration & Device Listing

Proprietary Name: Speed-Torque®
Classification Name: WIRE, GUIDE, CATHETER, EXEMPT
FDA Product Code: PTL
FDA Classification: Class II, 510(k) Exempt
Regulation Medical Specialty: Cardiovascular
Regulation Number: 870.1330
GMP Exempt: No

Clinically Differentiated

The Speed-Torque provides numerous advantages over current devices:

Summary of Benefits

  • Allows reposition of device without losing eye contact of view screen
  • Maintain absolute control of wire during device repositioning
  • Increased back support during wire manipulation
  • Reduction in wire retraction or advancement due to loss of wire control
  • Shorter fluoro time
  • Lower radiation exposure to physician and Cath Lab Staff