# K093554: Retroflex Dilator Kit

- Pathway: 510(k) (Traditional)
- Applicant: Edwards Lifesciences, LLC
- Decided: Apr 13, 2010 after 147 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 K891022 (1989). 4 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070749: Estech Percutaneous Insertion Dilator Kit, Coombs Medical Device Consulting (2007) Summary page 1.
- K963388: Vessel Dilator, Maxxim Medical (1997) Summary page 1.
- K092378: Spectranetics Visisheath Dilator Sheath, Spectranetics Corp. (2009) Summary page 1.

## Most influential descendants
- K123842: Lawmax Dilator (2013), 1 descendant of its own
- K170616: van Andel Dilatation Catheter (2017), 0 descendants of its own

## Indications for use
The RetroFlex Dilator Kit is intended for use in dilation of the peripheral vasculature.

Source page: https://510kreport.com/device/K093554
Methodology: https://510kreport.com/methodology