HSA · registration DE0504478

Teleflex Turnpike™ Catheters

Name: Teleflex Turnpike™ Catheters — HSA DE0504478
Creator: Teleflex Medical LLC
Keywords: Teleflex Turnpike™ Catheters, Teleflex Turnpike™ Catheters, DE0504478, Cardiovascular, HSA

SingaporeCardiovascularClass DTeleflex Medical LLC

Verified

Official record identity

Registration number: DE0504478
Model name: Turnpike Gold Catheter; Turnpike Gold Catheter; Turnpike LP Catheter; Turnpike LP Catheter; Turnpike Spiral Catheter; Turnpike Spiral Catheter; Turnpike Catheter; Turnpike Catheter
Model identifier: 5621; 5622; 5638; 5639; 5640; 5641; 5642; 5643
Registration date: May 13, 2020
Source update date: September 29, 2025

Classification

Risk class: Class D
Published category: Cardiovascular

Published parties

Product owner: Teleflex Medical LLC
Registrant / registration holder: TELEFLEX MEDICAL ASIA PTE. LTD.

Official description

The Turnpike catheters are intended to be used to access discrete regions of the coronary and/or peripheral vasculature. They may be used to facilitate placement and exchange of guidewires, to subselectively infuse/deliver diagnostic and therapeutic agents, and to assist in crossing de novo coronary chronic total occlusions (CTO).

Additional source fields

Product owner address: 3015 Carrington Mill Blvd. Morrisville, North Carolina, 27560, USA, United States
Registrant address: 83 CLEMENCEAU AVENUE, #05-05-08, UE SQUARE, Singapore 239920

About this record

This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.