Search Results
Found 4 results
510(k) Data Aggregation
K Number
K213251Device Name
HANAROSTENT Esophagus Asymmetric (CCC)
Manufacturer
M.I.Tech Co., Ltd.
Date Cleared
2021-11-18
(49 days)
Product Code
ESW
Regulation Number
878.3610Why did this record match?
Applicant Name (Manufacturer) :
M.I.Tech Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The HANAROSTENT® Esophagus Asymmetric (CCC) is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistula.
Device Description
This self-expanding tubular prosthesis is designed to maintain patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas. It consists of a self-expandable metal stent and a delivery device. The self-expandable metal stent is made of nickel titanium alloy (Nitinol) wire with fully covered silicone membrane, and the delivery device is made of polymeric materials. The stent is loaded into the distal part of the delivery device, and expanded in the body by pulling the outer sheath of the delivery device. The HANAROSTENT® Esophagus Asymmetric (CCC) is intended for single use only.
Ask a Question
K Number
K202973Device Name
HANAROSTENT Benefit Biliary (NNN)
Manufacturer
M.I.Tech Co., Ltd.
Date Cleared
2021-05-11
(223 days)
Product Code
FGE
Regulation Number
876.5010Why did this record match?
Applicant Name (Manufacturer) :
M.I.Tech Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The HANAROSTENT® Benefit™ Biliary (NNN) is indicated for the palliation of malignant strictures in the biliary tree.
Device Description
The HANAROSTENT® Benefit™ Biliary (NNN) is a self-expanding tubular prosthesis designed to maintain patency of biliary obstructions caused by malignant tumors. It consists of a self-expandable metal stent and a delivery device. The self-expandable metal stent is made of nickel titanium alloy (Nitinol) wire. The delivery device is made of polymeric materials. The stent is loaded into the distal part of the delivery device, and expanded in the body by pulling the outer sheath of the delivery device. The stent and delivery device are provided sterile and are intended for single use only.
Ask a Question
K Number
K190141Device Name
HANAROSTENT LowAx Colon/Rectum (NNN)
Manufacturer
M.I.Tech Co., Ltd.
Date Cleared
2019-03-07
(37 days)
Product Code
MQR
Regulation Number
878.3610Why did this record match?
Applicant Name (Manufacturer) :
M.I.Tech Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The HANAROSTENT® LowAxTM Colon/Rectum (NNN) is indicated for the palliative treatment of colorectal strictures caused by malignant neoplasms and to relieve large bowel obstruction prior to colectomy in patients with malignant strictures.
Device Description
This self-expanding tubular prosthesis designed to maintain patency of colorectal obstructions caused by malignant tumors. It consists of a self-expandable metal stent and a delivery system. The self-expandable metal stent is made of nickel titanium alloy (Nitinol) wire and the delivery system is made of polymeric materials. The stent is loaded into the distal part of the delivery system. The HANAROSTENT® LowAxTM Colon/Rectum (NNN) is intended for single use only.
Ask a Question
K Number
K183396Device Name
HANAROSTENT FASTTM Biliary (NNN)
Manufacturer
M.I.Tech Co., Ltd.
Date Cleared
2019-02-11
(66 days)
Product Code
FGE
Regulation Number
876.5010Why did this record match?
Applicant Name (Manufacturer) :
M.I.Tech Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The HANAROSTENT® FAST™ Biliary (NNN) is indicated for the palliation of malignant strictures in the biliary tree.
Device Description
This self-expanding tubular prosthesis is designed to maintain patency of bile duct obstructions caused by malignant tumors. It consists of a self-expandable metal stent and a delivery system. The self-expandable metal stent is made of nickel titanium alloy (Nitinol) wire, and the delivery system is made of polymeric materials. The stent is loaded into the distal part of the delivery system, and expanded in the body by pulling the outer sheath of the delivery system. The HANAROSTENT® FAST™ Biliary (NNN) is intended for single use only.
Ask a Question
Page 1 of 1