← Back to catalogue

Models 6917T, 6917AT & 4951M Epicardial Pace Leads

FDA 510(k)

Class III (US FDA 510(k))

510(k) K921124

by Medtronic Vascular

Identifiers

510(k) Number
K921124 FDA 510(k)
FDA Product Code
DTB FDA 510(k)
Models / Variants
6917t FDA 510(k)
6917at FDA 510(k)
4951m Epicardial Pace Leads 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
SESP Substantially Equivalent — Postmarket Surveillance FDA 510(k)

These devices are permanent pacemaker electrodes designed for epicardial pacing. They deliver electrical stimulation to the heart muscle from the outer surface of the heart, facilitating cardiac rhythm regulation in patients requiring temporary or permanent pacing support during or after cardiac surgery.

The leads are intended for use in cardiac surgery settings and are supplied as single-use, sterile devices. Each model (6917T, 6917AT, and 4951M) is classified under FDA product code DTB and holds a 510(k) clearance (K921124). They are regulated under 21 CFR 870.3680 and must comply with Class III medical device standards for permanent pacemaker electrodes.

Frequently asked questions

Are these epicardial pace leads designed for temporary or permanent use in patients, and what specific surgical contexts are they intended for?

These leads (models 6917T, 6917AT, and 4951M) are permanent pacemaker electrodes intended for epicardial pacing, meaning they deliver electrical stimulation to the heart’s outer surface to regulate rhythm. While they can support temporary or permanent pacing, their primary use is in cardiac surgery settings, such as procedures requiring immediate or postoperative pacing support. They are not intended for general cardiac rhythm management outside of surgical contexts.

How are these leads supplied, and what does the single-use designation mean for clinical workflows?

The leads are supplied as sterile, single-use devices, meaning each package is intended for one patient procedure only. This designation simplifies clinical workflows by eliminating the need for reprocessing or sterilization between uses, reducing infection risks and ensuring consistent performance. Clinicians should discard unused leads after opening the sterile packaging.

Are there different models available, and if so, how do their specifications or intended applications differ?

Yes, there are three models: 6917T, 6917AT, and 4951M, all classified under FDA product code DTB for permanent pacemaker electrodes. While the exact technical differences (e.g., electrode design, conductor materials) aren’t specified in the data, their commonality lies in epicardial pacing for cardiac surgery. The models may vary in features like lead length, fixation mechanisms, or connector types, but all adhere to Class III regulatory standards (21 CFR 870.3680) and are cleared via FDA’s 510(k) pathway (K921124).

What regulatory pathway and classification apply to these leads, and how does that affect their use in clinical settings?

These leads are Class III devices under 21 CFR 870.3680, regulated as permanent pacemaker electrodes. They received FDA 510(k) clearance (K921124) through a traditional review process with input from the Cardiovascular (CV) Advisory Committee, indicating they meet stringent safety and effectiveness standards for epicardial pacing. Clinicians should confirm compliance with the manufacturer’s instructions and institutional protocols, as Class III classification implies higher scrutiny for devices with potential life-sustaining implications.

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: Models 6917t, 6917at & 4951m Epicardial Pace Leads, Epicardial Pace Leads - Medtronic Vascular | FDA Evidence Review, PDF K921124 - Models 6917t, 6917at & 4951m Epicardial Pace Leads, K921124 - MODELS 6917T | FDA 510 (k) | Medtronic Vascular

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Medtronic Vascular

Sources (1)

  • FDA 510(k) K921124 24 fields · synced Oct 6, 2026