# K193181: Serranator PTA Serration Balloon Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Cagent Vascular, LLC
- Decided: Apr 15, 2020 after 149 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.
1 later device descends from it; 1 cites it directly.
0 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142983: AngioSculpt PTA Scoring Balloon Catheter with HydroCross Coating, Angioscore, Inc. (2015) Summary page 4.

## Most influential descendants
- K203437: Serranator PTA Serration Balloon Catheter (2020), 0 descendants of its own

## Indications for use
The Serranator® PTA Serration Balloon Catheter is intended for dilatation of lesions in infrapopliteal arteries. Not for use in the coronary or neuro-vasculature.

Source page: https://510kreport.com/device/K193181
Methodology: https://510kreport.com/methodology