# K141148: Evolution RL Controlled-Rotation Dilator Sheath Set, Evolution Shortie RL Controlled-Rotation Dilator Sheath Set

- Pathway: 510(k) (Traditional)
- Applicant: Cook Vascular, Inc.
- Decided: Jul 1, 2014 after 57 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.
2 later devices descend from it; 2 cite it directly.
0 of 4 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
- K261310: FlexTract Deflectable-Rotational Dilator Sheath Set (2026), 0 descendants of its own
- K142301: Evolution Mechanical Dilator Sheath Set, Evolution Shortie Mechanical Dilator Sheath Set, SteadySheath Evolution Tissue Stabilization Sheath, SteadySheath Evolution Shortie Tissue Stabilization Sheath (2014), 0 descendants of its own

## Indications for use
The Evolution® RL Controlled-Rotation Dilator Sheath Set and the Evolution® Shortie RL Controlled-Rotation Dilator Sheath Set are intended for use in patients requiring the percutaneous dilation of tisue surrounding cardiac leads, indwelling catheters and foreign objects.

Source page: https://510kreport.com/device/K141148
Methodology: https://510kreport.com/methodology