# K991811: Cordis Maxi DS Pta Balloon Catheter

- Pathway: 510(k) (Special)
- Applicant: Cordis Corp.
- Decided: Jun 15, 1999 after 19 days
- Product code: LIT (Catheter, Angioplasty, Peripheral, Transluminal)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: 1 (0 Class I)
- 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 Opta5 PTA Balloon Catheter: named in the summary without a submission number
- (no number) Cordis Maxi LD PTA Balloon Catheter: named in the summary without a submission number

## Recalls of this device
- Oct 4, 2019 · Class II · Z-0250-2020: Product was manufactured utilizing an expired inner body.

## Indications for use
The Maxi DS PTA balloon Catheter intended use is to dilate stenoses in iliac, femoral, ilio femoral, popliteal, infra-popliteal, and renal arteries and the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. In addition, the Maxi DS catheters are also indicated for deployment of Palmaz Balloon expandable stents for the biliary system.

Source page: https://510kreport.com/device/K991811
Methodology: https://510kreport.com/methodology