# K193495: XO Score Percutaneous Transluminal Angioplasty Scoring Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Transit Scientific
- Decided: May 29, 2020 after 164 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). 46 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 49 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 4.
- K113103: Splitwire Percutaneous Transluminal Angioplasty Scoring Device, Rex Medical (2012) Summary page 4.

## Most influential descendants
- K221986: XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score LP Catheter (2022), 1 descendant of its own
- K232258: XO Constrain™ Percutaneous Transluminal Angioplasty Constraining Catheter (2024), 0 descendants of its own

## Indications for use
The XO Score Percutaneous Transluminal Angioplasty Scoring Catheter is intended to be used in conjunction with a PTA balloon to facilitate dilation and apposition of the scoring surface to the stenotic material in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries; and for treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Not for use in the coronary or neuro-vasculature.

Source page: https://510kreport.com/device/K193495
Methodology: https://510kreport.com/methodology