Model 5311B A-V Pacing System Analyzer
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K910595 FDA 510(k)
- FDA Product Code
- DTC FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.3630 FDA 510(k)
- Regulation Number
- 870.3630 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Model 5311B A-V Pacing System Analyzer is a diagnostic tool designed to assess the functionality of atrioventricular pacemakers. It measures parameters such as pacing thresholds, lead impedance, and sensing capabilities to evaluate pacemaker performance.
This device is used during implantation and follow-up evaluations to ensure optimal pacemaker function and patient safety. It is supplied as a non-sterile, reusable analyzer for cardiovascular applications and is authorized under FDA 510(k) clearance K910595.
Frequently asked questions
What is the Model 5311B A-V Pacing System Analyzer used for?
It is a diagnostic tool designed to assess the functionality of atrioventricular pacemakers by measuring pacing thresholds, lead impedance, and sensing capabilities to evaluate pacemaker performance during implantation and follow-up evaluations.
Is the Model 5311B A-V Pacing System Analyzer sterile or non-sterile, and is it reusable?
The device is supplied as a non-sterile, reusable analyzer for cardiovascular applications, meaning it is intended for multiple uses after appropriate cleaning and disinfection between patients.
What regulatory authorization does the Model 5311B A-V Pacing System Analyzer have?
It is authorized under FDA 510(k) clearance K910595, indicating it was found substantially equivalent to a legally marketed predicate device for its intended use as a pacemaker system analyzer.
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: Model 5311b A-V Pacing System Analyzer - Medtronic Vascular | FDA Reference, Claude Haiku 4.5 System Card, Medtronic Model 5311B A-V Pacing System Analyzer - Medtronic Vascular ..., Claude Sonnet 4.6 System Card
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K910595 | Class II | Active |
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Manufacturer
- Manufacturer
- Medtronic Vascular
Sources (1)
- FDA 510(k) K910595 24 fields · synced Oct 6, 2026