Isolator Surgical Ablation System A000019

GUDID 10840143901553

Ablation and Sensing Unit

ATRICURE, INC.

Cardiac radio-frequency ablation system generator

• Primary Device ID: 10840143901553
• NIH Device Record Key: 9899ec49-5229-4b6e-922b-fcd0fc5f0266
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Isolator Surgical Ablation System
• Version Model Number: ASU2
• Catalog Number: A000019
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 866-449-2342
• Email: sehlert@atricure.com
• Phone: 866-449-2342
• Email: sehlert@atricure.com
• Phone: 866-449-2342
• Email: sehlert@atricure.com

Operating and Storage Conditions

• Handling Environment Temperature: Between -45 Degrees Celsius and 54 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -45 Degrees Celsius and 54 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -45 Degrees Celsius and 54 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00818354010206 [Previous]
GS1	10840143901553 [Direct Marking]
GS1	30840143902950 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P100046

FDA Product Code

• OCM: Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation

Sterilization

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

[10840143901553]

High-level Disinfectant

[10840143901553]

High-level Disinfectant

[10840143901553]

High-level Disinfectant

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-02-16
• Device Publish Date: 2026-02-06

On-Brand Devices [Isolator Surgical Ablation System]

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• 00818354016345: Glidepath Tape (1-Unit)
• 00818354011326: Glidepath Tape (3-Unit)
• 00818354011135: Isolator Long Pen TT, 33 cm long pen
• 00818354011043: Isolator Synergy Access Surgical Ablation System
• 00818354010893: Coolrail Linear Pen, 30 mm linear electrode
• 00818354010824: Isolator Synergy Surgical Ablation System, Glidepath Tape, Left Curve
• 00818354010756: Isolator Synergy Surgical Ablation System, Glidepath Tape, Right Curve
• 00818354010473: Isolator Linear Pen, 20 mm linear electrode
• 00818354010435: Glidepath Tape (3-Unit)
• 00818354010343: Isolator Transpolar Pen
• 00818354016499: Coolrail Linear Pen, 30 mm linear electrode
• 30840143902103: Isolator Linear Pen, 20 mm linear electrode
• 30840143902523: Isolator Long Pen TT, 33 cm long pen
• 30840143902455: Coolrail Linear Pen, 30 mm linear electrode
• 30840143902387: Isolator Synergy Surgical Ablation System, Glidepath Tape, Left Curve
• 30840143902257: Isolator Synergy Surgical Ablation System, Glidepath Tape, Right Curve
• 30840143901984: Isolator Transpolar Pen
• 30840143900000: Isolator Synergy Access Surgical Ablation System
• 30840143901618: Glidepath Tape (GPT200) (3-Unit)
• 30840143901595: Glidepath Tape (GPT100) (1-Unit)
• 10840143901553: Ablation and Sensing Unit