HSA · registration DE0009648

Cook Approach Hydro ST Microwire Guide

Name: Cook Approach Hydro ST Microwire Guide — HSA DE0009648
Creator: Cook Medical Incorporated
Keywords: Cook Approach Hydro ST Microwire Guide, Cook Approach Hydro ST Microwire Guide, DE0009648, General Hospital, HSA

SingaporeGeneral HospitalClass BCook Medical Incorporated

Verified

Official record identity

Registration number: DE0009648
Model name: Approach Hydro ST Micro Wire Guide with Hydrophilic Coating; Approach Hydro ST Micro Wire Guide with Hydrophilic Coating; Approach Hydro ST Micro Wire Guide with Hydrophilic Coating
Model identifier: HMW-14-135-ST; HMW-14-190-ST; HMW-14-300-ST
Registration date: August 29, 2012
Source update date: October 28, 2021

Classification

Risk class: Class B
Published category: General Hospital

Published parties

Product owner: Cook Medical Incorporated
Registrant / registration holder: COOK SOUTH EAST ASIA PTE LTD

Official description

Intended for use in facilitating delivery of percutaneous catheters into the peripheral vasculature.

Additional source fields

Product owner address: 1025 Acuff Road,, P.O. Box 4195, Bloomington, IN 47402-4195, United States
Registrant address: 38 BEACH ROAD, #29-11, SOUTH BEACH TOWER, Singapore 189767

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.