# K241478: Tri-Wedge PTA Scoring Balloon Dilatation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Brosmed Medical Co., Ltd.
- Decided: Oct 22, 2024 after 151 days
- Product code: PNO (Catheter, Percutaneous, Cutting/Scoring)
- 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
Longest line of descent: 13 generations back to K971448 (1997). 45 ancestors in all.
No later device cites it as a predicate yet.
0 of 46 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150634: AngioSculpt PTA Scoring Baloon Catheters, Spectranetrics (2015) Summary page 5.

## Indications for use
Tri-Wedge PTA Scoring Balloon Dilatation Catheter is indicated to dilate stenoses in the iliac, femoral, iliofemoral, popliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Source page: https://510kreport.com/device/K241478
Methodology: https://510kreport.com/methodology