Unipolar & Bioplar Implantable Endocardial Pacing Leads, With Silicone Rubber I…
FDA 510(k)Class III (US FDA 510(k))
Identifiers
- 510(k) Number
- K953044 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 Permanent Pacemaker Electrode designed for endocardial pacing. It features unipolar and bipolar configurations with silicone rubber insulation and passive fixation mechanisms to secure the lead within the heart chamber. These leads are intended for implantation to provide electrical stimulation for cardiac rhythm management in patients requiring pacing support.
The leads are supplied sterile and intended for single-use implantation. They are classified as Class III medical devices under FDA regulations and have received FDA 510(k) clearance as substantially equivalent with tracking and post-market surveillance requirements. Compatible with MRI environments under specified conditions, these leads are distributed in sterile packaging and must be stored according to manufacturer instructions to maintain sterility and functionality.
Frequently asked questions
Are these pacing leads designed for reuse or are they intended for single-use only?
These leads are explicitly intended for single-use only after implantation. The device description and specifications confirm they are supplied sterile and must not be reused, ensuring patient safety and maintaining sterility standards.
What types of insulation and fixation mechanisms do these leads use, and why does this matter?
The leads feature silicone rubber insulation, which provides durability and biocompatibility for long-term cardiac implantation. They also include passive fixation mechanisms to securely anchor the lead within the heart chamber, reducing the risk of displacement and ensuring reliable pacing performance over time.
How should these leads be stored to maintain their sterility and functionality?
These leads must be stored according to the manufacturer’s instructions to preserve sterility and functionality. Since they are supplied sterile in packaging, exposure to moisture, contamination, or improper handling could compromise their integrity before use.
Are these leads compatible with MRI environments, and if so, under what conditions?
Yes, these leads are compatible with MRI environments under specified conditions, though exact parameters (e.g., field strength, imaging sequences) are not detailed in the provided data. Always refer to the manufacturer’s guidelines or labeling for precise MRI safety instructions to avoid risks like lead displacement or heating.
What regulatory pathway was followed for FDA clearance, and what ongoing requirements apply?
These leads received FDA 510(k) clearance under the *Traditional* pathway, determined to be *substantially equivalent* to a predicate device. They are classified as Class III and subject to tracking and post-market surveillance (PMS) requirements, ensuring continued monitoring of safety and performance after approval.
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 | K953044 | Class III | Active |
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Manufacturer
- Manufacturer
- Biotronik, Inc.
Sources (1)
- FDA 510(k) K953044 24 fields · synced Sep 18, 2026