Model 2188 Coronary Sinus Lead
FDA 510(k)Class III (US FDA 510(k))
Identifiers
- 510(k) Number
- K961936 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
- ST FDA 510(k)
The Model 2188 Coronary Sinus Lead is a Permanent Pacemaker Electrode (product code DTB), designed for coronary sinus placement to enable left ventricular pacing. This bipolar lead features a platinum alloy electrode tip and ring, facilitating precise electrical stimulation within the cardiac conduction system. It is intended for use in cardiac resynchronization therapy systems to improve ventricular coordination in patients with heart failure.
This device is supplied sterile and intended for single-use implantation. It is classified as a Class III medical device under FDA regulations (21 CFR 870.3680) and holds an FDA 510(k) clearance (K961936) under the Traditional review pathway, with Substantially Equivalent status subject to tracking. The lead is intended for use in cardiovascular procedures and must be handled under sterile conditions prior to implantation.
Frequently asked questions
What is the primary clinical purpose of the Model 2188 Coronary Sinus Lead, and how does it differ from standard pacemaker leads?
The Model 2188 Coronary Sinus Lead is specifically designed for coronary sinus placement to enable left ventricular pacing, which is critical for cardiac resynchronization therapy (CRT). Unlike standard pacemaker leads that typically target the right atrium or ventricle, this lead is engineered to stimulate the left ventricle indirectly via the coronary sinus, improving ventricular coordination in patients with heart failure. Its bipolar design with a platinum alloy electrode tip and ring ensures precise electrical stimulation within the cardiac conduction system.
Is the Model 2188 Coronary Sinus Lead reusable, or is it intended for single-use only?
The Model 2188 Coronary Sinus Lead is intended for single-use implantation only. It is supplied sterile and must be handled under sterile conditions prior to use, as per manufacturer guidelines. Reuse is not recommended or supported by the device’s design or regulatory classification.
What sizes or models of the Model 2188 Coronary Sinus Lead are available, and how are they differentiated?
The provided data does not specify individual size or model variations beyond the Model 2188 designation. However, the device is listed with multiple FEI numbers (e.g., 3002618605, 1028232), which may correspond to different lot or batch identifiers rather than distinct sizes. For precise sizing or model-specific details, refer to the manufacturer’s technical documentation or catalog, as these FEI numbers are administrative identifiers tied to regulatory tracking, not clinical specifications.
How should the Model 2188 Coronary Sinus Lead be stored, and what precautions should be taken?
The Model 2188 Coronary Sinus Lead is supplied sterile, so storage must maintain sterility until implantation. It should be kept in its original packaging, protected from contamination, moisture, or physical damage. Follow the manufacturer’s storage instructions (e.g., room temperature, dry conditions) to preserve functionality. Avoid exposure to extreme temperatures or direct sunlight, as these could compromise the lead’s integrity or sterility.
What regulatory pathway was used for the FDA clearance of the Model 2188 Coronary Sinus Lead, and what does this mean for its use?
The Model 2188 Coronary Sinus Lead received FDA 510(k) clearance (K961936) under the Traditional review pathway, with a Substantially Equivalent (ST) status subject to tracking. This means the device was determined to be comparable to a legally marketed predicate device in terms of technology and safety. Clinically, this clearance confirms the lead meets FDA standards for coronary sinus placement and cardiac resynchronization therapy, but it does not imply any additional clinical indications beyond those explicitly stated in the device description.
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. Sources consulted: Coronary sinus pacing lead(Model 2188, Medtronic , Inc.) It is a... | Download Scientific Diagram, Model 2188 Coronary Sinus Lead - Medtronic Vascular | FDA Reference, MODEL 2188 CORONARY SINUS LEAD. (K961936) - FDA 510 (k)
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K961936 | Class III | Active |
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Manufacturer
- Manufacturer
- Medtronic Vascular
Sources (1)
- FDA 510(k) K961936 24 fields · synced Oct 6, 2026