# P050018: Angiosculpt Scoring Balloon Catheter

- Pathway: PMA
- Applicant: Spectranetics Corp.
- Decided: Jan 8, 2007 after 607 days
- Product code: NWX (Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring)
- Device class: 3
- Recalls of this device: 3 (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. PMA decisions do not claim a predicate device.

## Recalls of this device
- Dec 7, 2018 · Class II · Z-0576-2020: The incorrect outer carton box was used for the product.
- Dec 4, 2009 · Not classified · Z-2218-2010: Separations of the PTCA catheter shaft at the guide wire exit port have occurred during treatment of coronary artery stenosis. Fragments of the catheter may become lodged in coronary arteries, which r
- Nov 13, 2007 · Not classified · Z-0591-2008: Mis-labeling: Product labeling on product pouch indicates wrong size, the correct size is on the product carton

Source page: https://510kreport.com/device/P050018
Methodology: https://510kreport.com/methodology