Bipolar Implantable Endocardial Pacing Leads, With Silicone Rubber Insulation and Passive Fixation
FDA 510(k)Class III (US FDA 510(k))
Identifiers
- 510(k) Number
- K964604 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
- PT FDA 510(k)
This device is a bipolar implantable endocardial pacing lead designed for cardiac pacing applications. It delivers electrical impulses to the heart’s endocardium to regulate rhythm, featuring silicone rubber insulation and passive fixation for secure positioning within the cardiac chambers. The lead is intended for use with implantable cardiac pacemakers to support patients with bradycardia or conduction disorders.
The leads are supplied sterile and intended for single-use implantation via the venous system. They are classified as Class III devices under FDA regulations and have received FDA 510(k) clearance (K964604) as substantially equivalent to predicate devices. Compatible with MRI environments under specified conditions, these leads are packaged individually for sterile surgical use and must be handled according to aseptic techniques. Multiple sizes and configurations are available, as referenced in the device’s registration numbers.
Frequently asked questions
Are these leads reusable or intended for single-use only, and what does that mean for handling during surgery?
These leads are intended for single-use only and are supplied sterile in individually packaged sterile surgical sets. This means each lead should be used for one patient only and must be handled with aseptic techniques to maintain sterility before implantation. Reusing them would violate sterility standards and pose infection risks.
What types of patients or conditions are these leads designed to support, and how do they work?
These leads are designed for patients with bradycardia or conduction disorders who require cardiac pacing. They deliver electrical impulses to the heart’s endocardium (inner lining of the heart chambers) via a bipolar design, helping regulate abnormal heart rhythms. They are implanted via the venous system and work in conjunction with an implantable cardiac pacemaker.
How many sizes or configurations are available, and how do I identify the correct one for a patient?
Multiple sizes and configurations are available, as referenced by the registration numbers (e.g., 2017865, 3002618605, etc.). The correct size depends on the patient’s anatomy and the specific pacing requirements, which should be determined by the clinician in consultation with the manufacturer’s sizing guidelines. Biotronik’s technical documentation or a representative can assist in selecting the appropriate lead for a given case.
Can these leads be used in patients who require MRI scans, and if so, what conditions apply?
Yes, these leads are compatible with MRI environments under specified conditions. However, the exact parameters (e.g., MRI machine type, field strength, and imaging sequences) must be followed to ensure safety. Always refer to the manufacturer’s MRI safety information or consult Biotronik’s technical support before proceeding with MRI for a patient with these leads implanted.
How should these leads be stored before use, and what precautions should be taken?
These leads are packaged individually for sterile surgical use and must be stored in their original, unopened packaging to preserve sterility. They should be kept in a clean, dry environment away from direct sunlight or extreme temperatures. Before use, verify the packaging is intact and handle the lead using aseptic techniques to prevent contamination. Discard any compromised or expired leads.
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: Bipolar Implantable Endocardial Pacing Leads, With Silicone Rubber ..., Unipolar & Bioplar Implantable Endocardial Pacing Leads, With Silicone ..., Unipolar & Bioplar Implantable Endocardial Pacing Leads, With Silicone ..., 510(k) Premarket Notification
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K964604 | Class III | Active |
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Manufacturer
- Manufacturer
- Biotronik, Inc.
Sources (1)
- FDA 510(k) K964604 24 fields · synced Sep 18, 2026