# K140047: Lexiconture Mechanical Dilator Sheath Set

- Pathway: 510(k) (Traditional)
- Applicant: Spectranetics Corp.
- Decided: Apr 9, 2014 after 90 days
- Product code: DRE (Dilator, Vessel, For Percutaneous Catheterization)
- Device class: 2
- Regulation: 21 CFR 870.1310
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K061000 (2006). 1 ancestor in all.
7 later devices descend from it; 3 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061000: Evolution Mechanical Dilator Sheath Set Models-LR-Evn-7.0, LR-Evn-9.0, Cook Vascular, Inc. (2006) Summary page 1.

## Most influential descendants
- K141131: Tightrail Mini (2014), 6 descendants of its own
- K142546: TightRail Rotating Dilator Sheath/TightRail Mini Dilator Sheath (2014), 5 descendants of its own
- K150360: TightRail Rotating Dilator Sheath, TightRail Mini Rotating Dilator Sheath (2015), 3 descendants of its own
- K161333: TightRail Sub-C Rotating Dilator Sheath (2016), 2 descendants of its own
- K212784: TightRail Guardian Motorized Dilator Sheath (2022), 1 descendant of its own

## Indications for use
The TightRail Mechanical Dilator Sheath is intended for use in patients requiring the percutaneous dilation of tissue to facilitate removal of cardiac leads, indwelling catheters and foreign objects.

Source page: https://510kreport.com/device/K140047
Methodology: https://510kreport.com/methodology