# K992825: Cordis Extreme Pta Balloon Catheter

- Pathway: 510(k) (Special)
- Applicant: Cordis Corp.
- Decided: Sep 15, 1999 after 23 days
- Product code: LIT (Catheter, Angioplasty, Peripheral, Transluminal)
- 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Cordis PowerFlex™ Plus PTA Balloon Catheter: named in the summary without a submission number

## Indications for use
The Cordis PowerFlex EXTREME PTA Balloon Catheter is indicated for treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae and to dilate stenoses in iliac, femoral, ilio-femoral, popliteal, infra popliteal and renal arteries

Source page: https://510kreport.com/device/K992825
Methodology: https://510kreport.com/methodology