# K971448: Cordis Opta LP Pta Balloon Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Cordis Corp.
- Decided: Jul 3, 1997 after 73 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.
96 later devices descend from it; 5 cite it directly.
0 of 97 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) Cordis Small Vessel PTA Balloon Catheter: named in the summary without a submission number
- (no number) Cordis Savvy PTA Balloon Catheter: named in the summary without a submission number
- (no number) Meditech UltraThin Balloon Catheter: named in the summary without a submission number

## Most influential descendants
- K013581: Cordis Aviator Peripheral Dilatation Catheter (2001), 65 descendants of its own
- K050629: Angiosculpt Scoring Balloon Catheter (2005), 38 descendants of its own
- K072225: Angiosculpt Pta Scoring Balloon Catheter (2007), 37 descendants of its own
- K080151: Angiosculpt Pta Scoring Balloon Catheter, Models 2076 and 2039 (2008), 36 descendants of its own
- K082059: Angiosculpt Pta Scoring Balloon Catheter (2008), 34 descendants of its own

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

Source page: https://510kreport.com/device/K971448
Methodology: https://510kreport.com/methodology