Advisor HD Grid X Mapping Catheter, Sensor Enabled
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K241372 FDA 510(k)
- FDA Product Code
- MTD FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1220 FDA 510(k)
- Regulation Number
- 870.1220 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Advisor HD Grid X Mapping Catheter, Sensor Enabled is an intracardiac mapping catheter with a high-density array. It is designed for use in electrophysiology procedures to assist in mapping cardiac tissue.
This device is supplied by Abbott Medical and is a Class II medical device. It is indicated for use in cardiovascular procedures and has received FDA 510(k) clearance with the K number K241372. The device is not indicated for patients with prosthetic valves or those with left atrial conditions.
Frequently asked questions
What is the Advisor HD Grid X Mapping Catheter used for?
The Advisor HD Grid X Mapping Catheter is an intracardiac mapping catheter with a high-density array designed for use in electrophysiology procedures to assist in mapping cardiac tissue.
How is the Advisor HD Grid X Mapping Catheter supplied?
The device is supplied by Abbott Medical as a Class II medical device. It is indicated for use in cardiovascular procedures but is not indicated for patients with prosthetic valves or those with left atrial conditions.
What is the regulatory status of the Advisor HD Grid X Mapping Catheter?
The device has received FDA 510(k) clearance with the K number K241372. It was determined to be substantially equivalent and received special clearance type through the Cardiovascular advisory committee.
Is the Advisor HD Grid X Mapping Catheter single-use or reusable?
The device data does not specify whether the Advisor HD Grid X Mapping Catheter is single-use or reusable. This information would be available in the product's instructions for use provided by the manufacturer.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: ADVISOR HD GRID MAPPING CATHETER, SENSOR ENABLED - Abbott, Advisor HD Grid X - electrophysiology.abbott.com, About Advisor HD Grid X | Abbott, PDF Advisor™ HD Grid Mapping Catheter, Sensor Enable
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K241372 | Class II | Active |
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Manufacturer
- Manufacturer
- Abbott Medical
Sources (1)
- FDA 510(k) K241372 24 fields · synced Sep 26, 2026