EndoCATH 2006

GUDID 00818354017571

Large Occlusion Balloon Catheter

ATRICURE, INC.

Intravascular occluding balloon catheter, image-guided

• Primary Device ID: 00818354017571
• NIH Device Record Key: 1c50c68a-0170-4ac5-a2b6-37b92ebc3ccc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EndoCATH
• Version Model Number: 2006
• Catalog Number: 2006
• Company DUNS: 006133784
• Company Name: ATRICURE, 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: false
• 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

Customer Support Contacts

• Phone: 1-855-256-7330
• Email: info@sentreheart.com
• Phone: 1-855-256-7330
• Email: info@sentreheart.com
• Phone: 1-855-256-7330
• Email: info@sentreheart.com
• Phone: 1-855-256-7330
• Email: info@sentreheart.com
• Phone: 1-855-256-7330
• Email: info@sentreheart.com
• Phone: 1-855-256-7330
• Email: info@sentreheart.com
• Phone: 1-855-256-7330
• Email: info@sentreheart.com
• Phone: 1-855-256-7330
• Email: info@sentreheart.com
• Phone: 1-855-256-7330
• Email: info@sentreheart.com
• Phone: 1-855-256-7330
• Email: info@sentreheart.com
• Phone: 1-855-256-7330
• Email: info@sentreheart.com
• Phone: 1-855-256-7330
• Email: info@sentreheart.com
• Phone: 1-855-256-7330
• Email: info@sentreheart.com
• Phone: 1-855-256-7330
• Email: info@sentreheart.com
• Phone: 1-855-256-7330
• Email: info@sentreheart.com
• Phone: 1-855-256-7330
• Email: info@sentreheart.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00818354017571 [Primary]
HIBCC	M95520060 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070126

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: 2019-12-31
• Device Publish Date: 2019-12-23

On-Brand Devices [EndoCATH ]

• 00818354017571: Large Occlusion Balloon Catheter
• 30840143901700: Large Occlusion Balloon Catheter
• 30840143903667: Large Occlusion Balloon Catheter
• 30840143909409: Large Occlusion Balloon Catheter