# K202187: FLEX Vessel Prep System

- Pathway: 510(k) (Traditional)
- Applicant: Venturemed Group, Inc.
- Decided: Sep 11, 2020 after 38 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: 4 generations back to K971010 (1997). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152789: Flex Scoring Catheter, Venturemed Group (2016) Summary page 5.

## Indications for use
The FLEX Vessel Prep™ System 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. The device is also indicated for treatment of in-stent restenosis of balloon expandable and self-expanding stents in the peripheral vasculature.

Source page: https://510kreport.com/device/K202187
Methodology: https://510kreport.com/methodology