INT,K2 Microcatheter

GUDID 26950900955789

1.8F-2.5F, 130cm, curved tip

Shanghai Kindly Medical Instruments Co., Ltd.

Coronary artery infusion catheter Coronary artery infusion catheter Coronary artery infusion catheter Coronary artery infusion catheter Coronary artery infusion catheter Coronary artery infusion catheter Coronary artery infusion catheter Coronary artery infusion catheter Coronary artery infusion catheter Coronary artery infusion catheter Coronary artery infusion catheter Coronary artery infusion catheter Coronary artery infusion catheter

• Primary Device ID: 26950900955789
• NIH Device Record Key: 3d5c3a65-1fe2-4cf6-b938-3484b9d15e20
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INT,K2 Microcatheter
• Version Model Number: MCM02-1
• Company DUNS: 420827639
• Company Name: Shanghai Kindly Medical Instruments Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06950900955785 [Primary]
GS1	26950900955789 [Package]; Contains: 06950900955785; Package: box [5 Units]; In Commercial Distribution
GS1	46950900955783 [Package]; Contains: 06950900955785; Package: carton [25 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201706

FDA Product Code

• DQY: Catheter, Percutaneous

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-06
• Device Publish Date: 2023-08-29

On-Brand Devices [INT,K2 Microcatheter]

• 26950900998939: 1.8F-2.5F, 180cm, curved tip,fully hydrophilic coating
• 26950900998922: 1.8F-2.5F, 150cm, curved tip,fully hydrophilic coating
• 26950900998915: 1.8F-2.5F, 130cm, curved tip,fully hydrophilic coating
• 26950900998908: 1.8F-2.5F, 110cm, curved tip,fully hydrophilic coating
• 26950900998892: 1.6F-2.3F, 180cm, curved tip,fully hydrophilic coating
• 26950900998885: 1.6F-2.3F, 150cm,, curved tip,fully hydrophilic coating
• 26950900998878: 1.6F-2.3F, 130cm, curved tip,fully hydrophilic coating
• 26950900998861: 1.6F-2.3F, 110cm, curved tip,fully hydrophilic coating
• 26950900998854: 1.8F-2.5F, 180cm, straight tip,fully hydrophilic coating
• 26950900998847: 1.8F-2.5F, 150cm, straight tip,fully hydrophilic coating
• 26950900998830: 1.8F-2.5F, 130cm, straight tip,fully hydrophilic coating
• 26950900998823: 1.8F-2.5F, 110cm, straight tip,fully hydrophilic coating
• 26950900998816: 1.6F-2.3F, 180cm, straight tip,fully hydrophilic coating
• 26950900998809: 1.6F-2.3F, 150cm, straight tip,fully hydrophilic coating
• 26950900998793: 1.6F-2.3F, 130cm, straight tip,fully hydrophilic coating
• 26950900998786: 1.6F-2.3F, 110cm, straight tip,fully hydrophilic coating
• 26950900955802: 1.8F-2.5F, 180cm, curved tip
• 26950900955796: 1.8F-2.5F, 150cm, curved tip
• 26950900955789: 1.8F-2.5F, 130cm, curved tip
• 26950900955772: 1.8F-2.5F, 110cm, curved tip
• 26950900955765: 1.6F-2.3F, 180cm, curved tip
• 26950900955758: 1.6F-2.3F, 150cm,, curved tip
• 26950900955741: 1.6F-2.3F, 130cm, curved tip
• 26950900955734: 1.6F-2.3F, 110cm, curved tip
• 26950900955710: 2.8F-3.0F, 150cm, straight tip
• 26950900955703: 2.8F-3.0F, 130cm, straight tip
• 26950900955604: 1.8F-2.5F, 180cm, straight tip
• 26950900955598: 1.8F-2.5F, 150cm, straight tip
• 26950900955581: 1.8F-2.5F, 110cm, straight tip
• 26950900955574: 1.6F-2.3F, 180cm, straight tip
• 26950900955567: 1.6F-2.3F, 110cm, straight tip
• 26950900934319: 1.6F-2.3F, 150cm, straight tip
• 26950900934289: 1.8F-2.5F, 130cm, straight tip
• 26950900929643: 1.6F-2.3F, 130cm, straight tip