# K061000: Evolution Mechanical Dilator Sheath Set Models-LR-Evn-7.0, LR-Evn-9.0

- Pathway: 510(k) (Special)
- Applicant: Cook Vascular, Inc.
- Decided: May 10, 2006 after 29 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
No predicates in its family tree.
11 later devices descend from it; 3 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K140047: Lexiconture Mechanical Dilator Sheath Set (2014), 7 descendants of its own
- 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

## Indications for use
The Cook Vascular EVOLUTION Mechanical Dilator Sheath Set is for use in the percutaneous dilation of tissue surrounding cardiac leads, indwelling catheters and foreign objects.

Source page: https://510kreport.com/device/K061000
Methodology: https://510kreport.com/methodology