# K072156: Optimus 0.035 Inch Pta Balloon Dilatation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Usci Ireland
- Decided: Nov 9, 2007 after 98 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: 1 generation back to K032737 (2003). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032737: Cordis Powerflex Extreme Pta Balloon Catheter, Cordis Powerflex Plus Pta Balloon Catheter, Cordis Powerflex P3 Pta, Cordis Europa, N.V. (2003) Summary page 1.

## Most influential descendants
- K082646: Optimus 0.035 Pta Balloon Dilatation Catheter (2008), 0 descendants of its own

## Indications for use
The OPTIMUS 0.035" PTA Balloon Dilation Catheter is intended to dilate stenoses in the Iliac, Femoral, Popliteal and Renal arteries.

Source page: https://510kreport.com/device/K072156
Methodology: https://510kreport.com/methodology