Ablamap® System

GUDID 00860457001568

The Ablamap® System is an electrophysiology mapping system for assisting in the diagnosis of complex cardiac arrhythmias. The system consists of several hardware elements including an amplifier, cart, monitor, and workstation that contains proprietary mapping software. Signals are transmitted from a 64-electrode mapping “basket” catheter, through the amplifier, to the workstation, processed by the mapping software, and the results are displayed on the monitor.

Ablacon Inc.

Cardiac mapping system computer

• Primary Device ID: 00860457001568
• NIH Device Record Key: 7cfcbc68-fb05-4ee0-9f15-b77f1912faa7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ablamap® System
• Version Model Number: AB-0007
• Company DUNS: 106083214
• Company Name: Ablacon Inc.
• Device Count: 1
• DM Exempt: true
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860457001568 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230008

FDA Product Code

• DQK: Computer, Diagnostic, Programmable

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-12-15
• Device Publish Date: 2023-12-07

Devices Manufactured by Ablacon Inc.

• 00860457001513 - Ablacath Catheter Extension Cable: 2025-03-03 Catheter extension cable
• 00860457001520 - Ablacath System Interconnect Cable: 2025-03-03 System interconnect cable
• 00860457001544 - Ablacon™ Mapping Catheter: 2023-12-15 The Ablacath™ Mapping Catheter may be used to detect electrical potentials from the endocardial surfaces of the heart. These
• 00860457001551 - Ablacon™ Mapping Catheter: 2023-12-15 The Ablacath™ Mapping Catheter may be used to detect electrical potentials from the endocardial surfaces of the heart. These
• 00860457001568 - Ablamap® System: 2023-12-15The Ablamap® System is an electrophysiology mapping system for assisting in the diagnosis of complex cardiac arrhythmias. The system consists of several hardware elements including an amplifier, cart, monitor, and workstation that contains proprietary mapping software. Signals are transmitted from a 64-electrode mapping “basket” catheter, through the amplifier, to the workstation, processed by the mapping software, and the results are displayed on the monitor.
• 00860457001568 - Ablamap® System: 2023-12-15 The Ablamap® System is an electrophysiology mapping system for assisting in the diagnosis of complex cardiac arrhythmias. The s