# K220704: Serranator PTA Serration Balloon Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Cagent Vascular, LLC
- Decided: May 4, 2022 after 55 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: 13 generations back to K971448 (1997). 45 ancestors in all.
No later device cites it as a predicate yet.
0 of 46 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213728: Serranator PTA Serration Balloon Catheter, Cagent Vascular, LLC (2021) Summary page 4.

## Indications for use
The Serranator® PTA Serration Balloon Catheter is intended for dilatation of lesions in the iliac, femoral, iliofemoral, popliteal, infrapopliteal arteries and 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/K220704
Methodology: https://510kreport.com/methodology