# K113103: Splitwire Percutaneous Transluminal Angioplasty Scoring Device

- Pathway: 510(k) (Traditional)
- Applicant: Rex Medical
- Decided: May 22, 2012 after 216 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: 2 generations back to K971010 (1997). 5 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063657: Vascutrak Pta Dilation Catheter, Ymed, Inc. (2006) Summary page 4.

## Most influential descendants
- K193495: XO Score Percutaneous Transluminal Angioplasty Scoring Catheter (2020), 2 descendants of its own
- K221986: XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score LP Catheter (2022), 1 descendant of its own
- K152789: Flex Scoring Catheter (2016), 1 descendant of its own
- K232258: XO Constrain™ Percutaneous Transluminal Angioplasty Constraining Catheter (2024), 0 descendants of its own
- K202187: FLEX Vessel Prep System (2020), 0 descendants of its own

## Indications for use
The SplitWire Percutaneous Transluminal Angioplasty Scoring device is indicated for the use with percutaneous transluminal angioplasty (PTA) catheters to facilitate dilation of stenoses in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries and treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Source page: https://510kreport.com/device/K113103
Methodology: https://510kreport.com/methodology