Identifiers
- 510(k) Number
- K772203 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 Ventricular Leads are classified as Permanent Pacemaker Electrodes, designed for implantation within the heart to stimulate ventricular contraction. These leads facilitate cardiac pacing by delivering electrical impulses to the right ventricle, ensuring proper heart rhythm and function in patients with bradycardia or conduction system disorders.
These leads are supplied sterile and intended for single-use implantation during cardiac procedures. They are regulated under FDA 510(k) clearance (K772203) and fall under the Cardiovascular advisory committee classification. Compatible with pacemaker systems, they are available in multiple reference codes (e.g., 3002618605, 1028232) and adhere to regulatory standards outlined in 870.3680. Storage and handling must follow sterile medical device protocols.
Frequently asked questions
Are these ventricular leads designed for reuse in multiple patients, or are they intended for single-use only during a single procedure?
These ventricular leads are explicitly intended for single-use only during cardiac implantation procedures. The manufacturer’s documentation states they are supplied sterile and must not be reused, aligning with standard sterile medical device protocols.
What types of pacemaker systems are these leads compatible with, and how do I confirm compatibility before use?
These ventricular leads are designed to be compatible with Medtronic’s pacemaker systems, though exact compatibility should be verified against the specific model’s technical documentation or the manufacturer’s guidelines. The leads are categorized under permanent pacemaker electrodes and are regulated under FDA 510(k) clearance, ensuring they meet established safety and performance standards for use with approved pacing systems.
How should these leads be stored to maintain their sterility and functionality before use in a procedure?
Since these leads are supplied sterile, they must be stored according to sterile medical device protocols—typically in their original packaging, protected from contamination, and within the manufacturer’s recommended temperature and humidity ranges. Avoid exposure to moisture, direct sunlight, or extreme temperatures, as this could compromise sterility or integrity.
What are the key differences between the various reference codes (e.g., 3002618605, 1028232) listed for these ventricular leads?
The reference codes listed correspond to specific models or variants of the ventricular leads, which may differ in design features (e.g., electrode configuration, lead length, or fixation mechanisms) but share the same core function of ventricular stimulation. To determine the exact differences, consult the manufacturer’s product catalog or technical datasheet for each code, as these variations are not described in the provided regulatory data.
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 | K772203 | Class III | Active |
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Manufacturer
- Manufacturer
- Medtronic Vascular
Sources (1)
- FDA 510(k) K772203 24 fields · synced Oct 6, 2026