# K955886: Mega Pta Balloon Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Cordis Corp.
- Decided: Mar 11, 1996 after 74 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 Savvy PTA Balloon Catheter: named in the summary without a submission number
- (no number) Cordis Opta 5 PTA Balloon Catheter: named in the summary without a submission number
- (no number) Cordis Small Vessel PTA Balloon Catheter: named in the summary without a submission number
- (no number) Schneider SofTrac: named in the summary without a submission number

## Indications for use
The Cordis Mega PTA Balloon Catheters are designed for dilatation of stenotic lesions within the peripheral vessels.

Source page: https://510kreport.com/device/K955886
Methodology: https://510kreport.com/methodology