# K043401: Spectranetics LLD CS, Model 518-039

- Pathway: 510(k) (Traditional)
- Applicant: Spectranetics Corp.
- Decided: Mar 16, 2005 after 96 days
- Product code: DRB (Stylet, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1380
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K970690 (1997). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990713: Spectranetics Lead Locking Device (LLD) #1, #2, #3 Lister, Spectranetics Corp. (1999) Summary page 1.

## Indications for use
The Spectranetics LLD E is intended for use in patients suitable for transvenous removal of chronically implanted pacing or defibrillator leads having an inner lumen and using the superior venous approach. The lead inner lumen must have an inner diameter (ID) range from 0.015 - 0.026 inches (0.38 - 0.66 mm) and a length less than 33.5 inches (85 cm).

Source page: https://510kreport.com/device/K043401
Methodology: https://510kreport.com/methodology