Model 2331T Patient Programmer
FDA 510(k)Class III (US FDA 510(k))
Identifiers
- 510(k) Number
- K880738 FDA 510(k)
- FDA Product Code
- KRG FDA 510(k)
Classification
- Device Class
- Class III FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.3700 FDA 510(k)
- Regulation Number
- 870.3700 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Model 2331T Patient Programmer is a medical device classified as a programmer for pacemakers and implantable cardioverter-defibrillators (ICDs). It is designed to interface with these implanted cardiac devices to program, monitor, and retrieve data from them, enabling clinicians to adjust settings and assess patient status remotely or in-clinic.
This device is intended for use in clinical settings such as hospitals, cardiac care units, and outpatient electrophysiology laboratories. Supplied as a reusable electronic unit, it operates in non-MRI environments and requires proper calibration and maintenance. Authorized under FDA 510(k) clearance (K880738) as substantially equivalent to a predicate device, it adheres to regulatory standards outlined in 21 CFR 870.3700 for cardiovascular devices.
Frequently asked questions
What types of implanted cardiac devices can the Model 2331T Patient Programmer interface with, and where is it typically used?
The Model 2331T Patient Programmer is designed to interface specifically with pacemakers and implantable cardioverter-defibrillators (ICDs). It is intended for use in clinical settings such as hospitals, cardiac care units, and outpatient electrophysiology laboratories, where clinicians can program, monitor, and retrieve data from these implanted devices to adjust settings and assess patient status.
Is the Model 2331T Patient Programmer a single-use or reusable device, and what maintenance does it require?
The Model 2331T Patient Programmer is supplied as a reusable electronic unit. Since it is an electronic device, it requires proper calibration and maintenance to ensure accurate programming and monitoring of pacemakers and ICDs. Regular upkeep is essential for reliable performance in clinical environments.
Can the Model 2331T Patient Programmer be used in an MRI environment, and what regulatory pathway was followed for its approval?
No, the Model 2331T Patient Programmer is explicitly designed for use in non-MRI environments. It was authorized under the FDA’s 510(k) clearance process (K880738) as substantially equivalent to a predicate device, adhering to regulatory standards outlined in 21 CFR 870.3700 for cardiovascular devices.
What is the primary purpose of the Model 2331T Patient Programmer, and how does it support remote or in-clinic patient management?
The primary purpose of the Model 2331T Patient Programmer is to enable clinicians to program, monitor, and retrieve data from pacemakers and ICDs. This allows for remote or in-clinic adjustments to device settings and assessment of patient status, facilitating better cardiac care management in controlled clinical environments.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K880738 | Class III | Active |
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Manufacturer
- Manufacturer
- Medtronic Vascular
Sources (1)
- FDA 510(k) K880738 24 fields · synced Oct 6, 2026