Medtronic Model 5513 Endocardial Pacing Lead
FDA 510(k)Class III (US FDA 510(k))
Identifiers
- 510(k) Number
- K870885 FDA 510(k)
- FDA Product Code
- DTB FDA 510(k)
Classification
- Device Class
- Class III FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.3680 FDA 510(k)
- Regulation Number
- 870.3680 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Medtronic Model 5513 Endocardial Pacing Lead is a permanent pacemaker electrode designed for endocardial pacing. This device delivers electrical stimulation to the heart’s inner lining to regulate cardiac rhythm in patients with bradycardia or conduction disorders, ensuring proper heart function through precise pacing signals.
This lead is intended for use in cardiac electrophysiology procedures, typically implanted via the venous system into the right atrium or ventricle. Supplied sterile and intended for single-use, it adheres to FDA 510(k) clearance under the traditional review pathway. Compliance with regulatory standards ensures safe integration with pacemaker systems, with no specific MRI safety restrictions noted in the data. The device is categorized under OpenFDA’s permanent pacemaker electrode classification, governed by regulation 870.3680.
Frequently asked questions
What is the primary clinical purpose of the Medtronic Model 5513 Endocardial Pacing Lead, and how does it function in the body?
The Medtronic Model 5513 Endocardial Pacing Lead is designed to regulate cardiac rhythm in patients with bradycardia or conduction disorders by delivering precise electrical stimulation to the heart’s inner lining (endocardium). It is implanted via the venous system into the right atrium or ventricle, where it provides pacing signals to ensure proper heart function.
Is this device intended for single-use or can it be reused after implantation?
The Medtronic Model 5513 Endocardial Pacing Lead is supplied sterile and explicitly intended for single-use only. Reuse is not recommended or supported by the manufacturer.
What regulatory pathway was followed for FDA clearance of this device, and what does that mean for its safety and compliance?
This device received FDA clearance under the traditional review pathway (510(k)) with a decision of *Substantially Equivalent* (SESE) to a predicate device. This means the FDA determined it meets regulatory standards for safety and effectiveness, ensuring it can be safely integrated with pacemaker systems as intended for endocardial pacing.
Are there any known restrictions on using this device with MRI procedures?
The provided data does not specify any MRI safety restrictions for the Medtronic Model 5513 Endocardial Pacing Lead. However, clinicians should always verify compatibility with their specific MRI system and protocols, as individual patient factors and device configurations may influence safety.
How is this lead categorized in regulatory databases, and what does that classification indicate?
The device is classified under **OpenFDA’s
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 | K870885 | Class III | Active |
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Manufacturer
- Manufacturer
- Medtronic Vascular
Sources (1)
- FDA 510(k) K870885 24 fields · synced Sep 18, 2026