ACIST Kodama® Coronary Imaging Catheter

GUDID 10841716103602

Kodama Catheter, Contents: Imaging catheter, 3 mL syringe, 10 mL syringe, Extension set, Sterile bag

ACIST MEDICAL SYSTEMS, INC.

Intravascular ultrasound imaging catheter, single-use

• Primary Device ID: 10841716103602
• NIH Device Record Key: f8db9845-3864-44c4-bf3e-4c84125ca616
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACIST Kodama® Coronary Imaging Catheter
• Version Model Number: 017788
• Company DUNS: 926684994
• Company Name: ACIST MEDICAL SYSTEMS, INC.
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10841716103602 [Primary]
GS1	30841716103606 [Package]; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193183

FDA Product Code

• OBJ: Catheter, Ultrasound, Intravascular

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: 2025-08-22
• Device Publish Date: 2025-08-14

On-Brand Devices [ACIST Kodama® Coronary Imaging Catheter]

• 10841716100755: Kodama Catheter, p/n 701470-001 Contents: Imaging catheter, 3 mL syringe, 10 mL syringe, Extensi
• 10841716103602: Kodama Catheter, Contents: Imaging catheter, 3 mL syringe, 10 mL syringe, Extension set, Sterile