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Medtronic #4951

FDA 510(k)

Class III (US FDA 510(k))

510(k) K812599

by Medtronic Vascular

Identifiers

510(k) Number
K812599 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 #4951 Epicardial Unipolar Lead is a permanent pacemaker electrode designed for epicardial cardiac pacing. It is intended for use in patients requiring electrical stimulation of the heart to maintain proper heart rhythm, typically in cases of bradycardia or conduction system disorders.

This device is supplied sterile and intended for single-use implantation. It is classified as a Class III medical device under FDA regulations (870.3680) and was cleared via the 510(k) pathway (K812599) in 1981. The lead is intended for use in cardiac electrophysiology procedures and must be handled under sterile conditions prior to implantation.

Frequently asked questions

What is the Medtronic #4951 Epicardial Unipolar Lead used for in clinical practice?

The Medtronic #4951 Epicardial Unipolar Lead is designed for epicardial cardiac pacing, providing electrical stimulation to maintain proper heart rhythm in patients with bradycardia or conduction system disorders. It is implanted to ensure consistent pacing when the heart’s natural electrical signals are insufficient.

Is the Medtronic #4951 Epicardial Unipolar Lead intended for reuse, or is it single-use only?

The device is explicitly labeled as intended for single-use implantation. It is supplied sterile and must be handled under sterile conditions before use, ensuring patient safety and preventing contamination.

How was the regulatory clearance for this device obtained, and what pathway was followed?

The Medtronic #4951 Epicardial Unipolar Lead was cleared via the FDA’s 510(k) pathway (K812599) in 1981, demonstrating substantial equivalence to a predicate device. It is classified as a Class III medical device under FDA regulations (870.3680), reflecting its critical role in cardiac electrophysiology.

What type of sterility assurance is provided with the Medtronic #4951 Epicardial Unipolar Lead?

The lead is supplied sterile, meaning it undergoes processing to eliminate or reduce viable microorganisms to ensure safety for direct implantation. This sterility is critical for preventing infection during cardiac pacing procedures.

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: Medtronic 4951 - Medtronic Vascular | FDA Evidence Review, MEDTRONIC #4951 (K812599) — FDA 510 (k) | Innolitics, Medtronic Model 4951P - Medtronic Vascular | FDA Reference, EPICARDIAL, UNIPOLAR LEAD 4951 (K842065) — FDA 510(k) | Innolitics

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Medtronic Vascular

Sources (1)

  • FDA 510(k) K812599 24 fields · synced Oct 6, 2026