# K141131: Tightrail Mini

- Pathway: 510(k) (Special)
- Applicant: Spectranetics, Inc.
- Decided: May 23, 2014 after 22 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: 2 generations back to K061000 (2006). 2 ancestors in all.
6 later devices descend from it; 1 cites 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)
- K140047: Lexiconture Mechanical Dilator Sheath Set, Spectranetics Corp. (2014) Summary page 2.

## Most influential descendants
- 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
- K223472: TightRail Guardian Motorized Dilator Sheath, 9 French (575-009); TightRail Guardian Motorized Dilator Sheath, 11 French (575-011); TightRail Guardian Motorized Dilator Sheath, 13 French (575-013) (2022), 0 descendants of its own

## Indications for use
The TightRail Mini Rotating 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/K141131
Methodology: https://510kreport.com/methodology