# K163380: Serranator Alto PTA Serration Balloon Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Cagent Vascular, LLC
- Decided: Feb 13, 2017 after 74 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: 11 generations back to K971448 (1997). 43 ancestors in all.
2 later devices descend 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)
- K122685: Angiosculpt Pta Scoring Balloon Catheter, Angioscore, Inc. (2013) Summary page 4.

## Most influential descendants
- K213728: Serranator PTA Serration Balloon Catheter (2021), 1 descendant of its own
- K220704: Serranator PTA Serration Balloon Catheter (2022), 0 descendants of its own

## Indications for use
The Serranator™ Alto PTA Serration Balloon Catheter is intended for dilatation of lesions in the iliac, femoral, ilio-femoral, and popliteal 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/K163380
Methodology: https://510kreport.com/methodology