# K972825: OPTA5 Pta Balloon Catheter, Powerflex Pta Balloon Catheter, Ultra-Thin Diamond Balloon Catheter, Palmaz Balloon Expandab

- Pathway: 510(k) (Traditional)
- Applicant: Cordis Corp.
- Decided: Oct 7, 1997 after 90 days
- Product code: FGE (Stents, Drains And Dilators For The Biliary Ducts)
- Device class: 2
- Regulation: 21 CFR 876.5010
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
20 later devices descend from it; 3 cite it directly.
0 of 21 devices 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 Powerflex PTA Balloon Catheter: named in the summary without a submission number
- (no number) Medi-tech Ultra-thin Diamond Balloon Dilatation Catheter: named in the summary without a submission number
- (no number) Cordis Palmaz and Palmaz-Schatz Balloon Expandable Stents: named in the summary without a submission number

## Most influential descendants
- K983055: RX Viatrac 14 Peripheral Dilatation Catheter, Model #'S 1003006-20, 1003007-20, 1003008-20, 1003009-20, 1003010-20, 1003 (1998), 11 descendants of its own
- K012050: Viatrac 14 Plus Peripheral Dilatation Catheter (2001), 7 descendants of its own
- K980653: Perflex Stainless Steel Stent and Delivery System (1998), 7 descendants of its own
- K072798: Viatrac 14 Plus Peripheral Dilation Catheter (2008), 6 descendants of its own
- K102705: Armada 14 Pta Catheter (2010), 4 descendants of its own

## Indications for use
Opta5 PTA Balloon Catheters are indicated for dilatation of stenoses in iliac, femoral, ilio-femoral, popliteal, infra-popliteal and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Powerflex PTA Balloon Catheters are indicated for dilatation of stenoses in iliac, femoral, popliteal and renal arteries. In addition, certain sizes of Opta5 and Powerflex catheters are also indicated for deployment of Palmaz and Palmaz-Schatz Balloon Expandable Stents for the biliary system.

Source page: https://510kreport.com/device/K972825
Methodology: https://510kreport.com/methodology