Implantable Pacing Leads W/Is-1 Conn., Unipolar
FDA 510(k)Class III (US FDA 510(k))
Identifiers
- 510(k) Number
- K894040 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 cardiac pacing applications. It delivers electrical impulses to stimulate the heart muscle, ensuring proper heart rhythm in patients with bradycardia or conduction disorders. The unipolar configuration provides a single electrode for pacing, connected via an IS-1 connector to external pacemaker systems.
The leads are intended for implantable use within the cardiovascular system, typically positioned in the right atrium or ventricle. Supplied sterile for single-use, they are classified as Class III medical devices under FDA regulations and require FDA 510(k) clearance. Compatible with MRI environments under specific conditions, they are distributed in sterile packaging for surgical implantation by qualified healthcare professionals.
Frequently asked questions
What is the primary purpose of these unipolar pacing leads, and where are they typically implanted in the body?
These unipolar pacing leads are designed to deliver electrical impulses to the heart muscle, helping maintain proper heart rhythm in patients with bradycardia or conduction disorders. They are intended for implantable use within the cardiovascular system, specifically positioned in the right atrium or right ventricle.
Are these leads meant for single-use or can they be reused after implantation?
The leads are supplied sterile for single-use only. They are intended for surgical implantation by qualified healthcare professionals and are not designed for reuse.
What type of connector do these leads use, and what external systems are they compatible with?
These leads use an IS-1 connector, which allows them to interface with external pacemaker systems designed for unipolar pacing configurations.
How are these leads packaged and stored before use, and what precautions should be taken?
The leads are supplied in sterile packaging to ensure sterility before surgical implantation. They must be stored according to manufacturer guidelines to maintain sterility and integrity until use.
Are these leads compatible with MRI environments, and if so, under what conditions?
Yes, these leads are designed to be compatible with MRI environments under specific conditions, though the exact parameters should be verified with the manufacturer’s instructions for safe use.
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 | K894040 | Class III | Active |
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Manufacturer
- Manufacturer
- Medtronic Vascular
Sources (1)
- FDA 510(k) K894040 24 fields · synced Oct 6, 2026