# K971579: Cordis Opta 5 Pta Balloon Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Cordis Corp.
- Decided: Jul 18, 1997 after 88 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) OPTA 5 PTA Catheters: named in the summary without a submission number
- (no number) JUPITER PTA Catheters: named in the summary without a submission number

## Indications for use
'The OptaS catheters are intended for balloon dilataticn of lesions in peripheral arteries (iliac, renal, popliteal, infra popliteal, femoral and ilio femoral) and are slso intended to ™ treat obstructive lesions of native or synihefic arteriovencus dialysis fistulae.

Source page: https://510kreport.com/device/K971579
Methodology: https://510kreport.com/methodology