HSA · registration DE0508413

Cook SteadySheath® Evolution® Shortie Tissue Stabilization Sheath

Name: Cook SteadySheath® Evolution® Shortie Tissue Stabilization Sheath — HSA DE0508413
Creator: Cook Vandergrift Inc
Keywords: Cook SteadySheath® Evolution® Shortie Tissue Stabilization Sheath, Cook SteadySheath® Evolution® Shortie Tissue Stabilization Sheath, DE0508413, Cardiovascular, HSA

SingaporeCardiovascularClass DCook Vandergrift Inc

Verified

Official record identity

Registration number: DE0508413
Model name: SteadySheath® Shortie 11 Fr Evolution® Tissue Stabilization Sheath; SteadySheath® Shortie 9 Fr Evolution® Tissue Stabilization Sheath
Model identifier: LR-TSS-SH-11.0; LR-TSS-SH-9.0
Registration date: August 18, 2023

Classification

Risk class: Class D
Published category: Cardiovascular

Published parties

Product owner: Cook Vandergrift Inc
Registrant / registration holder: COOK SOUTH EAST ASIA PTE LTD

Official description

The Cook SteadySheath® Evolution® Shortie Tissue Stabilization Sheath is intended for use in patients requiring the percutaneous dilation of tissue surrounding cardiac leads, indwelling catheters and foreign objects.

Additional source fields

Product owner address: 1186 Montgomery Lane, Vandergrift, Pennsylvania 15690, 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.