# K213728: Serranator PTA Serration Balloon Catheter

- Pathway: 510(k) (Special)
- Applicant: Cagent Vascular, LLC
- Decided: Dec 15, 2021 after 19 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: 12 generations back to K971448 (1997). 44 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 46 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163380: Serranator Alto PTA Serration Balloon Catheter, Cagent Vascular, LLC (2017) Summary page 4.

## Most influential descendants
- K220704: Serranator PTA Serration Balloon Catheter (2022), 0 descendants of its own

## Indications for use
The Serranator® PTA Serration Balloon Catheter is intended for dilatation of lesions in the iliac, femoral, iliofemoral, and popliteal arteries for the 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/K213728
Methodology: https://510kreport.com/methodology