# K232258: XO Constrain™ Percutaneous Transluminal Angioplasty Constraining Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Transit Scientific, LLC
- Decided: Jun 17, 2024 after 322 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: 15 generations back to K971448 (1997). 48 ancestors in all.
No later device cites it as a predicate yet.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221986: XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score LP Catheter, Transit Scientific, LLC (2022) Summary page 5.

## Indications for use
The XO Constrain Percutaneous Transluminal Angioplasty Constraining Catheter is intended to be used in conjunction with a PTA balloon to facilitate dilation and apposition of the scoring/constraining surface to the stenotic material in the iliac, femoral, ilio-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/K232258
Methodology: https://510kreport.com/methodology