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Model 6208, 6209, 6210, 6211, 6212, 6214 (PLI’s)

FDA 510(k)

Class III (US FDA 510(k))

510(k) K890045

by Medtronic Vascular

Identifiers

510(k) Number
K890045 FDA 510(k)
FDA Product Code
DTB FDA 510(k)
Models / Variants
6208 FDA 510(k)
6209 FDA 510(k)
6210 FDA 510(k)
6211 FDA 510(k)
6212 FDA 510(k)
6214 (pli's) 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 Model 6208, 6209, 6210, 6211, 6212, and 6214 are Permanent Pacemaker Electrodes, designed for implantation in the cardiovascular system to stimulate the heart and regulate its rhythm. These devices are intended for use in patients requiring chronic cardiac pacing, delivering electrical impulses to correct abnormal heartbeats or maintain proper heart function.

These electrodes are supplied sterile and intended for single-use. They are classified as Class III medical devices under FDA regulations and were granted 510(k) clearance through a traditional review process by the Cardiovascular Advisory Committee. Models are available in various configurations, and proper handling, storage, and implantation procedures must adhere to manufacturer guidelines to ensure safety and efficacy.

Frequently asked questions

What types of patients are these permanent pacemaker electrodes designed for?

These electrodes (Models 6208, 6209, 6210, 6211, 6212, and 6214) are specifically intended for patients requiring chronic cardiac pacing. They deliver electrical impulses to correct abnormal heart rhythms or maintain proper heart function in individuals with conditions like bradycardia or heart block, where the heart’s natural electrical system is insufficient.

Are these electrodes single-use or reusable, and how should they be stored?

These electrodes are sterile and intended for single-use only. They must be stored according to Medtronic’s guidelines to preserve sterility, typically in their original packaging away from moisture, extreme temperatures, and direct sunlight. Always check the manufacturer’s instructions for specific storage conditions before use.

What regulatory pathway was followed for FDA clearance, and which advisory committee reviewed this device?

These electrodes received FDA 510(k) clearance through a traditional review process by the Cardiovascular (CV) Advisory Committee. The clearance was granted under the classification of Class III medical devices, indicating higher regulatory scrutiny due to their critical role in cardiac function.

How do I determine which model is appropriate for my patient’s needs?

The models (6208, 6209, 6210, 6211, 6212, and 6214) are available in various configurations, likely tailored to different implantation sites or pacing requirements. Consult Medtronic’s product documentation or a clinical specialist to select the correct model based on your patient’s anatomy, pacing needs, and procedural approach.

What safety precautions should be taken during handling and implantation?

Since these electrodes are sterile and single-use, they must be handled with aseptic technique to avoid contamination. Implantation should follow Medtronic’s manufacturer guidelines, including proper lead positioning, secure fixation, and adherence to sterile field protocols. Improper handling or reuse could compromise patient safety and device performance.

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

United States Active

FDA_510K

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Manufacturer

Manufacturer
Medtronic Vascular

Sources (1)

  • FDA 510(k) K890045 24 fields · synced Oct 6, 2026