# K101117: Lev-or Dilation Catheter Otw

- Pathway: 510(k) (Traditional)
- Applicant: Baylis Medical Co., Inc.
- Decided: Jul 16, 2010 after 86 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K001992 (2000). 15 ancestors in all.
No later device cites it as a predicate yet.
1 of 16 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060327: Vascular Solutions Twin-Pass Dual Access Catheter and Skyway Support Catheter, Vascular Solutions, Inc. (2006) Summary page 1.
- K070372: Gopher 2F Support Catheter, Model 5600 and Gopher 3F Support Catheter, Model 5610, Vascular Solutions, Inc. (2007) Summary page 1.

## Indications for use
The Lev-OR™ Dilation Catheter OTW is used to access discrete regions of the peripheral vasculature. It may be used to facilitate the placement and exchange of guidewires and other interventional devices and may be used for the infusion or delivery of diagnostic and/or therapeutic agents.

Source page: https://510kreport.com/device/K101117
Methodology: https://510kreport.com/methodology