# K152789: Flex Scoring Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Venturemed Group
- Decided: May 25, 2016 after 243 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: 3 generations back to K971010 (1997). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113103: Splitwire Percutaneous Transluminal Angioplasty Scoring Device, Rex Medical (2012) Summary page 5.

## Most influential descendants
- K202187: FLEX Vessel Prep System (2020), 0 descendants of its own

## Indications for use
The FLEX Scoring Catheter is indicated for use with percutaneous transluminal angioplasty (PTA) catheters to facilitate dilation of stenoses in the femoral and popliteal arteries and treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Source page: https://510kreport.com/device/K152789
Methodology: https://510kreport.com/methodology