Biotronik Endocardial Pacing Leads
FDA 510(k)Class III (US FDA 510(k))
Identifiers
- 510(k) Number
- K061212 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 Biotronik Endocardial Pacing Leads are classified as Permanent Pacemaker Electrodes, designed to deliver electrical stimulation to the heart’s endocardial tissue. These leads facilitate cardiac pacing by transmitting precise impulses to restore normal heart rhythm in patients with arrhythmias, heart block, or conduction disorders. They are engineered for reliable, long-term implantation within the cardiac chambers to support intrinsic cardiac function when endogenous pacing is insufficient. The device integrates with pacemaker systems to ensure synchronized and physiologic heart contractions.
These leads are intended for use in clinical settings such as electrophysiology labs and cardiac catheterization suites, where sterile implantation procedures are performed. They are supplied as single-use devices, adhering to FDA 510(k) clearance under Special Review (K061212) and classified under regulation 870.3680. Compatible with MRI environments under specified conditions, they are available in multiple model numbers (e.g., 3002618605, 3008377825) to accommodate various anatomical and pacing requirements. Storage follows manufacturer guidelines to preserve sterility and functionality prior to use.
Frequently asked questions
Are these pacing leads designed for long-term use in patients, and if so, how do they differ from temporary pacing solutions?
Yes, these Biotronik Endocardial Pacing Leads are specifically engineered for long-term implantation within the heart’s chambers, unlike temporary leads. They are intended to restore and maintain normal heart rhythm in patients with chronic arrhythmias, heart block, or conduction disorders by delivering precise electrical stimulation over extended periods. Temporary leads, in contrast, are typically used for short-term support (e.g., post-surgery or acute instability) and are not meant for permanent placement.
How are these leads supplied, and what precautions should be taken to ensure sterility before use?
These leads are supplied as single-use devices, meaning each unit is sterile and intended for one-time implantation only. Sterility is preserved through manufacturer-recommended storage conditions, which must be followed strictly to maintain functionality and safety. Always check the packaging for integrity and expiration dates before use, as compromised sterility could lead to infection or device failure.
What models are available, and how do I determine which one is best suited for my patient’s anatomical needs?
Biotronik offers multiple model numbers (e.g., 3002618605, 3008377825, and others listed under K061212) to accommodate different anatomical and pacing requirements. The selection depends on factors like the patient’s heart chamber (e.g., right atrium, right ventricle), lead length, and pacing configuration (e.g., single-coil, dual-coil). Consult the manufacturer’s specifications or a cardiologist to match the lead type to your patient’s specific clinical needs.
Can these leads be used in patients who require MRI scans, and what limitations or conditions apply?
Yes, these leads are compatible with MRI environments under specified conditions. However, compatibility depends on the MRI system’s magnetic field strength, sequence, and specific lead model. Always verify the manufacturer’s guidelines for each model to ensure safe imaging parameters are followed, as improper use could risk lead displacement or damage. Coordination with radiology and cardiology teams is recommended.
Where should these leads be stored before use, and how long can they remain unopened?
Storage must adhere to the manufacturer’s instructions to preserve sterility and functionality. Typically, leads should be stored in a clean, dry environment away from direct sunlight or extreme temperatures until use. Unopened leads have a shelf life indicated on the packaging—check the expiration date to ensure the device remains effective and safe for implantation. Never reuse or repurpose packaging.
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: Pacing Systems - Biotronik, biotronik endocardial pacing leads, Solia S | Biotronik, BIOTRONIK ENDOCARDIAL PACING LEADS (K061212) — FDA 510 (k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K061212 | Class III | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Biotronik, Inc.
Sources (1)
- FDA 510(k) K061212 24 fields · synced Sep 20, 2026