Transvenous Tined Ventricular/Atrial Electrode
FDA 510(k)Class III (US FDA 510(k))
Identifiers
- 510(k) Number
- K842031 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)
This device is a permanent pacemaker electrode, designed for transvenous placement to interface with the heart’s ventricular or atrial chambers. The tined design ensures secure fixation within the cardiac tissue, facilitating reliable electrical stimulation for pacing purposes in patients with bradycardia or conduction disorders.
The electrode is supplied sterile and intended for single-use implantation via venous access, adhering to Class III regulatory standards under FDA 510(k) clearance (K842031). It is compatible with MRI environments under specific conditions as outlined in the device labeling, with sizes and configurations standardized for compatibility with Medtronic Vascular pacemaker systems. Storage requires adherence to sterile packaging protocols to maintain integrity prior to use.
Frequently asked questions
What types of patients is this transvenous tined electrode designed to support, and how does the tined design benefit them?
This electrode is designed for patients with bradycardia or conduction disorders who require reliable cardiac pacing. The tined design ensures secure fixation within the heart’s ventricular or atrial chambers, reducing the risk of dislodgment and providing stable electrical stimulation for long-term pacing therapy.
Is this device compatible with MRI scans, and if so, what conditions must be met?
Yes, this electrode is compatible with MRI environments under specific conditions outlined in the device labeling. However, the exact parameters (e.g., MRI strength, imaging sequences) must be followed to ensure safety and performance during imaging.
How is this electrode supplied, and what storage precautions should be taken before use?
The electrode is supplied sterile and intended for single-use implantation. To maintain sterility and integrity, it must be stored according to the manufacturer’s sterile packaging protocols, ensuring the packaging remains unopened and undamaged until immediate use.
Are there different sizes or models available for this electrode, and how do they relate to Medtronic Vascular pacemaker systems?
Yes, this electrode comes in standardized sizes and configurations specifically designed for compatibility with Medtronic Vascular pacemaker systems. The sizing ensures proper fit and function within the heart’s chambers, optimizing pacing performance for different patient anatomies.
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 | K842031 | Class III | Active |
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Manufacturer
- Manufacturer
- Medtronic Vascular
Sources (1)
- FDA 510(k) K842031 24 fields · synced Oct 6, 2026