Mod Target/Tips #4011, 4012, 4511, 4512, 6912, 4016
FDA 510(k)Class III (US FDA 510(k))
Identifiers
- 510(k) Number
- K854582 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 Mod Target/Tips are Permanent Pacemaker Electrodes, designed for implantation in the cardiovascular system to facilitate cardiac pacing. These electrodes deliver electrical impulses to stimulate the heart muscle, ensuring proper heart rhythm in patients with bradycardia or other conduction disorders.
Supplied as single-use devices, the Mod Target/Tips are intended for sterile surgical implantation in a controlled clinical environment. Each model (#4011, 4012, 4511, 4512, 6912, 4016) is classified as Class III under FDA regulations and holds a Traditional 510(k) clearance (K854582). They are non-MRI-compatible and must be stored in their original packaging until use.
Frequently asked questions
What are the primary uses for the Mod Target/Tips electrodes in clinical practice?
The Mod Target/Tips electrodes are designed specifically for permanent pacemaker implantation in the cardiovascular system. They deliver electrical impulses to stimulate the heart muscle, helping to maintain proper heart rhythm in patients diagnosed with bradycardia or other conduction disorders. These electrodes are intended for sterile surgical use in controlled clinical environments.
Are these electrodes reusable, or are they meant for single-use only?
The Mod Target/Tips electrodes are supplied as single-use devices. They are intended for sterile surgical implantation and should not be reused after one procedure to ensure patient safety and device efficacy.
What storage instructions should be followed for these electrodes before use?
These electrodes must be stored in their original packaging until use. The packaging ensures sterility and protects the device from contamination or damage, which is critical for maintaining their performance during implantation.
Can these electrodes be used in patients who require MRI scans, or are they MRI-compatible?
The Mod Target/Tips electrodes are explicitly labeled as non-MRI-compatible. This means they should not be used in patients who require MRI scans, as the magnetic fields generated during an MRI could potentially interfere with or damage the device.
What models are available, and how do they differ from one another?
Six models are available: #4011, 4012, 4511, 4512, 6912, and 4016. While the exact differences between these models are not detailed in the provided data, they are all classified as permanent pacemaker electrodes and are intended for similar cardiovascular applications. The variations likely relate to electrode design, lead length, or tip configuration to suit different patient anatomies or clinical needs.
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 | K854582 | Class III | Active |
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Manufacturer
- Manufacturer
- Medtronic Vascular
Sources (1)
- FDA 510(k) K854582 24 fields · synced Oct 6, 2026