HSA · registration DE0510166

VASCULAR INNOVATIONS Cocoon Septal Occluder and Delivery System

Name: VASCULAR INNOVATIONS Cocoon Septal Occluder and Delivery System — HSA DE0510166
Creator: Vascular Innovations Co., Ltd.
Keywords: VASCULAR INNOVATIONS Cocoon Septal Occluder and Delivery System, VASCULAR INNOVATIONS Cocoon Septal Occluder and Delivery System, DE0510166, Cardiovascular, HSA

SingaporeCardiovascularClass DVascular Innovations Co., Ltd.

Verified

Official record identity

Registration number: DE0510166
Model name: Cocoon Sizing Balloon; Cocoon Sizing Balloon; Cocoon Delivery cable; Cocoon Septal Occluder; Cocoon Septal Occluder; Cocoon Septal Accessory set; Cocoon Septal Occluder; Cocoon Septal Accessory set; Cocoon Septal Occluder; Cocoon Septal Accessory set; Cocoon Septal Occluder; Cocoon Septal Occluder; Cocoon Septal Occluder; Cocoon Septal Occluder; Cocoon Septal Occluder; Cocoon Septal Occluder; Cocoon Septal Occluder; Cocoon Septal Occluder; Cocoon Septal Occluder; Cocoon Septal Occluder; Cocoon Septal Occluder; Cocoon Septal Occluder; Cocoon Septal Occluder; Cocoon Septal Accessory set; Cocoon Septal Accessory set; Cocoon Septal Accessory set; Cocoon Septal Accessory set
Model identifier: CAB24; CAB34; CDC6F; COA08; COA10; COA10F; COA12; COA12F; COA14; COA14F; COA16; COA18; COA20; COA22; COA24; COA26; COA28; COA30; COA32; COA34; COA36; COA38; COA40; COA6F; COA7F; COA8F; COA9F
Registration date: December 19, 2024

Classification

Risk class: Class D
Published category: Cardiovascular

Published parties

Product owner: Vascular Innovations Co., Ltd.
Registrant / registration holder: ANDAMAN MEDICAL PTE. LTD.

Official description

The Cocoon Septal Occluder is a percutaneous, transcatheter, atrial septal defect (ASD) closure device intended for the occlusion of secundum type ASD. Patients who have echocardiographic evidence of secundum atrial septal defect and right ventricular volume overload.

Additional source fields

Product owner address: 88/38 Moo 1, 345 Road, Bangtanai, Pakkret, Nonthaburi 11120, Thailand
Registrant address: 300 TAMPINES AVENUE 5, #09-02, INCOME AT TAMPINES JUNCTION, Singapore 529653

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.