# K082646: Optimus 0.035 Pta Balloon Dilatation Catheter

- Pathway: 510(k) (Special)
- Applicant: Usci Ireland
- Decided: Nov 3, 2008 after 53 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: 2 generations back to K032737 (2003). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072156: Optimus 0.035 Inch Pta Balloon Dilatation Catheter, Usci Ireland (2007) Summary page 1.
- 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.
- K042538: Sailor Plus Percutaneous Transluminal Angioplasty (Pta) Catheter, Model Saexxxxxxxxx, Invatec Innovative Technologies (2004) Summary page 1.

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

Source page: https://510kreport.com/device/K082646
Methodology: https://510kreport.com/methodology