# K092378: Spectranetics Visisheath Dilator Sheath

- Pathway: 510(k) (Traditional)
- Applicant: Spectranetics Corp.
- Decided: Nov 2, 2009 after 89 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.
4 later devices descend from it; 2 cite it directly.
0 of 5 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
- K093554: Retroflex Dilator Kit (2010), 2 descendants of its own
- K123842: Lawmax Dilator (2013), 1 descendant of its own
- K170616: van Andel Dilatation Catheter (2017), 0 descendants of its own
- K133631: Lexipliant Dilator Sheath Set (2014), 0 descendants of its own

## Indications for use
The VisiSheath Dilator Sheath is intended for Use in patients requiring the percutaneous dilation of tissue surrounding cardiac leads, indwelling catheters and foreign objects. The device is also intended for use in the introduction and support of intravascular catheters.

Source page: https://510kreport.com/device/K092378
Methodology: https://510kreport.com/methodology