# K142546: TightRail Rotating Dilator Sheath/TightRail Mini Dilator Sheath

- Pathway: 510(k) (Traditional)
- Applicant: Spectranetics, Inc.
- Decided: Sep 25, 2014 after 15 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: 3 generations back to K061000 (2006). 3 ancestors in all.
5 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)
- K140047: Lexiconture Mechanical Dilator Sheath Set, Spectranetics Corp. (2014) Summary page 4.
- K141131: Tightrail Mini, Spectranetics, Inc. (2014) Summary page 4.

## Most influential descendants
- 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
- K211679: Xtractor device (2022), 0 descendants of its own

## Indications for use
The TightRail and TightRail Mini Rotating Dilator Sheaths are 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/K142546
Methodology: https://510kreport.com/methodology