Medical Device Division · registration 140061Active

Cook

Name: Cook — Medical Device Division 140061
Creator: Cook Incorporated
Keywords: Cook, Cook, 140061, Catheters, Vascular, Angioplasty, Balloon, Medical Device Division

Hong KongCatheters, Vascular, Angioplasty, BalloonClass IVCook Incorporated

Verified

Official record identity

MDACS listing number: 140061
Model name: Advance Micro 14 Ultra Low-Profile PTA Balloon Catheter (PTA3-14-50-1.5-2, PTA3-14-50-1.5-4, PTA3-14-50-2-2, PTA3-14-50-2-3, PTA3-14-50-2-4, PTA3-14-50-2-6, PTA3-14-50-2-8, PTA3-14-50-2-10, PTA3-14-50-2-12, PTA3-14-50-2.5-2, PTA3-14-50-2.5-3, PTA3-14-50-2.5-4, PTA3-14-50-2.5-6, PTA3-14-50-2.5-8, PTA3-14-50-2.5-10, PTA3-14-50-2.5-12, PTA3-14-50-3-2, PTA3-14-50-3-3, PTA3-14-50-3-4, PTA3-14-50-3-6, PTA3-14-50-3-8, PTA3-14-50-3-10, PTA3-14-50-3-12, PTA3-14-90-1.5-2, PTA3-14-90-1.5-4, PTA3-14-90-2-2, PTA3-14-90-2-3, PTA3-14-90-2-4, PTA3-14-90-2-6, PTA3-14-90-2-8, PTA3-14-90-2-10, PTA3-14-90-2-12, PTA3-14-90-2.5-2, PTA3-14-90-2.5-3, PTA3-14-90-2.5-4, PTA3-14-90-2.5-6, PTA3-14-90-2.5-8, PTA3-14-90-2.5-10, PTA3-14-90-2.5-12, PTA3-14-90-3-2, PTA3-14-90-3-3, PTA3-14-90-3-4, PTA3-14-90-3-6, PTA3-14-90-3-8, PTA3-14-90-3-10, PTA3-14-90-3-12, PTA3-14-150-1.5-2, PTA3-14-150-1.5-4, PTA3-14-150-2-2, PTA3-14-150-2-3, PTA3-14-150-2-4, PTA3-14-150-2-6, PTA3-14-150-2-8, PTA3-14-150-2-10, PTA3-14-150-2-12, PTA3-14-150-2.5-2, PTA3-14-150-2.5-3, PTA3-14-150-2.5-4, PTA3-14-150-2.5-6, PTA3-14-150-2.5-8, PTA3-14-150-2.5-10, PTA3-14-150-2.5-12, PTA3-14-150-3-2, PTA3-14-150-3-3, PTA3-14-150-3-4, PTA3-14-150-3-6, PTA3-14-150-3-8, PTA3-14-150-3-10, PTA3-14-150-3-12)
Registration date: February 26, 2024
Expiry date: February 25, 2029
Source update date: May 02, 2025
Status: Active

Classification

Risk class: Class IV
Published category: Catheters, Vascular, Angioplasty, Balloon

Published parties

Registrant / registration holder: Cook Asia Ltd
Manufacturer: Cook Incorporated

Official description

Catheters, Vascular, Angioplasty, Balloon

Additional source fields

AMD nomenclature code: 17184
Local responsible person phone: 34721688
Published manufacturer address: 750 Daniels Way, Bloomington, Indiana 47404, USA.
Revision number: b

About this record

This page mirrors one official MDACS listing. Roman-numeral classes use Hong Kong’s general medical-device scheme, while letter classes use the IVD scheme. Valid, expired, and delisted records remain distinguishable; no mixed classification scale is fabricated.