Selethru NC PTCA Balloon Dilatation Catheter

Basic Information

• Brand Name: Selethru NC PTCA Balloon Dilatation Catheter
• Primary DI: 06971591765644
• Version / Model: KNC200030
• Company Name: Kossel Medtech (Suzhou) Co., Ltd.
• Labeler DUNS: 560219894
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-09-20
• Public Version: 1
• Public Version Date: 2021-09-28
• Public Version Status: New
• Public Device Record Key: 87a192cf-68e3-47c4-a27d-63135ab77201

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LOX	Catheters, Transluminal Coronary Angioplasty, Percutaneous	Cardiovascular	870.5100	2

GMDN Terms

Code	Name	Definition	Implantable	Status
17521	Coronary angioplasty balloon catheter, perfusing	A sterile, flexible tube designed for use in percutaneous transluminal coronary angioplasty (PTCA) to dilate a stenotic coronary artery by controlled inflation of a distensible balloon. The tube contains holes proximal and distal to the balloon that permit blood flow to the distal coronary arteries during balloon dilatation to protect the myocardium from haemodynamic compromise. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06971591765644	GS1

Premarket Submissions

Submission Number	Supplement Number
K211393	000