INT,K2 Microcatheter

Basic Information

• Brand Name: INT,K2 Microcatheter
• Primary DI: 06950900955563
• Version / Model: MCS01-0
• Company Name: Shanghai Kindly Medical Instruments Co., Ltd.
• Labeler DUNS: 420827639
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-08-29
• Public Version: 1
• Public Version Date: 2023-09-06
• Public Version Status: New
• Public Device Record Key: 3f36539a-daa6-48b0-9ac9-fa94b3c9a7b3

Device Description

1.6F-2.3F, 110cm, straight tip

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: Yes
• 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
DQY	Catheter, Percutaneous	Cardiovascular	870.1250	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36205	Coronary artery infusion catheter	A sterile flexible tube, typically with a double-lumen, designed to access the coronary artery vasculature for local infusion of diagnostic or therapeutic solutions (e.g., angiographic contrast medium, heparin solution, saline), and often to function as a passage for a guidewire to assist its placement in the coronary artery. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	26950900955567	GS1	box	5	In Commercial Distribution
Primary	06950900955563	GS1
Package	46950900955561	GS1	carton	25	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K201706	000