Spectranetics Lead Locking Device (LLD) #1, #2, #3 Lister
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K990713 FDA 510(k)
- FDA Product Code
- DRB FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1380 FDA 510(k)
- Regulation Number
- 870.1380 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Spectranetics Lead Locking Device (LLD) is a stylet and catheter locking mechanism designed to secure pacing leads within catheters. It belongs to the category of devices used in cardiovascular procedures to prevent dislodgement or displacement of leads during implantation or adjustment.
This device is supplied as a reusable medical instrument and is intended for use in controlled clinical settings, such as electrophysiology labs or cardiac catheterization suites. It is classified under FDA device class II and adheres to the Medical Device Directive (MDD) in Europe. The LLD is available in three sizes (#1, #2, #3) to accommodate different lead types, including the Lister lead, and is regulated under the FDA’s 510(k) clearance process with a traditional review pathway.
Frequently asked questions
What types of pacing leads is the Spectranetics Lead Locking Device (LLD) designed to secure, and how do the different sizes (#1, #2, #3) accommodate them?
The Spectranetics Lead Locking Device (LLD) is specifically designed to secure the Lister lead and other compatible pacing leads. The three sizes (#1, #2, #3) are engineered to accommodate different lead diameters or configurations, ensuring a secure fit within catheters during procedures like electrophysiology studies or cardiac catheterizations. This modular sizing allows clinicians to select the appropriate LLD based on the lead type being implanted or adjusted.
Is the Spectranetics Lead Locking Device reusable, and if so, what considerations should be taken during use and maintenance in a clinical setting?
Yes, the Spectranetics Lead Locking Device is supplied as a reusable medical instrument, intended for controlled clinical environments such as electrophysiology labs or cardiac catheterization suites. Since it is reusable, proper cleaning, sterilization, and maintenance protocols must be followed to ensure device integrity and prevent contamination between uses. Clinicians should adhere to manufacturer guidelines for reprocessing to maintain performance and safety.
How is the regulatory pathway for this device structured, and what does the FDA’s 510(k) clearance with a traditional review pathway entail?
The Spectranetics Lead Locking Device (LLD) follows the FDA’s 510(k) clearance process, classified under device class II and regulated under the traditional review pathway. This means the manufacturer demonstrated that the device is substantially equivalent to a legally marketed predicate device (in this case, a comparable stylet and catheter locking mechanism) in terms of safety and effectiveness. The traditional review involves a detailed submission reviewed by the FDA’s Cardiovascular (CV) advisory committee before clearance.
What clinical settings or procedures would most commonly utilize the Spectranetics Lead Locking Device?
The Spectranetics Lead Locking Device is primarily used in electrophysiology labs and cardiac catheterization suites during procedures involving pacing lead implantation or adjustment. Its purpose is to prevent dislodgement or displacement of leads within catheters, ensuring stability during critical phases of the procedure. This is particularly relevant in complex cardiovascular interventions where lead stability is critical for accurate diagnosis or treatment.
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 (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K990713 | Class II | Active |
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Manufacturer
- Manufacturer
- Spectranetics Corp.
Sources (2)
- FDA 510(k) K990713 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026