# K133631: Lexipliant Dilator Sheath Set

- Pathway: 510(k) (Traditional)
- Applicant: Spectranetics Corporation
- Decided: Mar 27, 2014 after 121 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 K092378 (2009). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092378: Spectranetics Visisheath Dilator Sheath, Spectranetics Corp. (2009) Summary page 2.

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

Source page: https://510kreport.com/device/K133631
Methodology: https://510kreport.com/methodology