Medtronic Model 6958 Permanent Pacemaker Electrode
FDA 510(k)Class III (US FDA 510(k))
Identifiers
- 510(k) Number
- K800870 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 6958 is a Permanent Pacemaker Electrode, classified as a Class III medical device under the FDA’s nomenclature. This device is designed for implantation within the cardiovascular system to facilitate cardiac pacing, ensuring proper electrical signaling to regulate heart rhythm in patients requiring chronic pacing support.
The Model 6958 is supplied sterile and intended for single-use implantation. It is regulated under FDA 510(k) clearance (K800870) and falls under the regulation number 870.3680, with advisory committee review by the Cardiovascular Panel. Storage and handling must comply with sterile medical device protocols, and its use is restricted to qualified healthcare professionals in clinical settings.
Frequently asked questions
What is the Medtronic Model 6958 used for in clinical practice?
The Medtronic Model 6958 is a permanent pacemaker electrode designed for implantation within the cardiovascular system to deliver chronic pacing support. It ensures proper electrical signaling to regulate heart rhythm in patients who require long-term pacing therapy, such as those with bradycardia or conduction system disorders.
Is the Medtronic Model 6958 intended for single-use or reusable applications?
The device is sterile and intended for single-use implantation only. This design ensures patient safety by preventing cross-contamination and maintaining sterility standards required for invasive cardiovascular procedures.
How should the Medtronic Model 6958 be stored to maintain its integrity?
Since it is a sterile medical device, the Model 6958 must be stored and handled according to sterile medical device protocols. This includes keeping it in its original packaging, protecting it from contamination, and adhering to manufacturer guidelines to preserve sterility until use.
What regulatory pathway does the Medtronic Model 6958 follow, and who oversees its review?
The device follows the FDA 510(k) clearance pathway, specifically under Traditional review with a substantially equivalent (SESE) determination. Its regulatory classification is Class III, and it falls under FDA regulation number 870.3680. The Cardiovascular (CV) Advisory Committee reviews submissions related to this product.
Who is authorized to use the Medtronic Model 6958, and where is it typically deployed?
The device is restricted to use by qualified healthcare professionals in clinical settings, such as hospitals or specialized electrophysiology labs. Its implantation requires expertise in cardiovascular procedures to ensure proper placement and function for chronic pacing support.
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 | K800870 | Class III | Active |
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Manufacturer
- Manufacturer
- Medtronic Vascular
Sources (1)
- FDA 510(k) K800870 24 fields · synced Oct 6, 2026