4 Fr PV Catheter CDL015

GUDID 08719327737316

4 Fr PV Loop catheter with 10 mm electrode spacing

CD Leycom

Intracardiac catheter-tip electrode Intracardiac catheter-tip electrode Intracardiac catheter-tip electrode Intracardiac catheter-tip electrode Intracardiac catheter-tip electrode Intracardiac catheter-tip electrode Intracardiac catheter-tip electrode Intracardiac catheter-tip electrode Intracardiac catheter-tip electrode Intracardiac catheter-tip electrode Intracardiac catheter-tip electrode Intracardiac catheter-tip electrode Intracardiac catheter-tip electrode Intracardiac catheter-tip electrode Intracardiac catheter-tip electrode Intracardiac catheter-tip electrode Intracardiac catheter-tip electrode Intracardiac catheter-tip electrode

• Primary Device ID: 08719327737316
• NIH Device Record Key: 9e3d40ac-ed32-489b-be3b-3354f8e2ae34
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 4 Fr PV Catheter
• Version Model Number: CA-41103-PN
• Catalog Number: CDL015
• Company DUNS: 414947457
• Company Name: CD Leycom
• 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: true
• 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	08719327737316 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K031599

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: 2023-09-28
• Device Publish Date: 2023-09-20

On-Brand Devices [4 Fr PV Catheter]

• 08719327737316: 4 Fr PV Loop catheter with 10 mm electrode spacing
• 08719327737309: 4 French PV Loop catheter with 6 mm electrode spacing