Medtronic 6957J Permanent Pacemaker Electrode
FDA 510(k)Class III (US FDA 510(k))
Identifiers
- 510(k) Number
- K843707 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 6957J is a Permanent Pacemaker Electrode, designed for implantation in the cardiovascular system to facilitate cardiac pacing. It delivers electrical impulses to regulate heart rhythm in patients with bradycardia or other conduction disorders, ensuring consistent and reliable cardiac function.
This device is intended for single-use implantation and is supplied sterile. It is classified as a Class III medical device under FDA regulations (21 CFR 870.3680) and requires FDA 510(k) clearance for market authorization. The electrode is compatible with Medtronic pacemaker systems and must be handled under aseptic conditions prior to use, adhering to standard surgical protocols for pacemaker lead placement.
Frequently asked questions
What is the Medtronic 6957J used for in clinical practice?
The Medtronic 6957J is a permanent pacemaker electrode designed to be implanted in the cardiovascular system. It delivers electrical impulses to regulate heart rhythm in patients with bradycardia or conduction disorders, ensuring consistent and reliable cardiac function. It is specifically engineered to work with Medtronic pacemaker systems.
Is the Medtronic 6957J intended for single-use or reusable implantation?
The Medtronic 6957J is intended for single-use implantation only. It is supplied sterile and must be handled under aseptic conditions prior to use, adhering to standard surgical protocols for pacemaker lead placement. Reuse is not recommended or supported by the manufacturer.
How is the Medtronic 6957J supplied, and what storage conditions should be followed?
The Medtronic 6957J is supplied sterile and packaged for single-use. While specific storage instructions are not detailed in the provided data, standard medical device protocols for pacemaker leads should be followed—typically, storage should be in a clean, dry environment away from direct sunlight or extreme temperatures until ready for use.
What regulatory pathway was followed for FDA clearance of the Medtronic 6957J?
The Medtronic 6957J underwent a traditional 510(k) clearance process through the FDA. It was classified as a Class III medical device under 21 CFR 870.3680 and was reviewed by the Cardiovascular (CV) Advisory Committee. The clearance decision was based on a finding of substantial equivalence to a predicate device, with the submission filed in 1984 and cleared in 1985.
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 | K843707 | Class III | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medtronic Vascular
Sources (1)
- FDA 510(k) K843707 24 fields · synced Oct 6, 2026