# K192907: Advocate PTA Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Merit Medical Systems, Inc.
- Decided: Nov 26, 2019 after 42 days
- Product code: LIT (Catheter, Angioplasty, Peripheral, Transluminal)
- 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 K001134 (2000). 34 ancestors in all.
No later device cites it as a predicate yet.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173621: Advocate PTA Catheter, Merit Medical Systems, Inc. (2017) Summary page 4.

## Indications for use
The Advocate PTA Catheter is intended for balloon dilation of the iliac, femoral, popliteal, infra-popliteal, renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Source page: https://510kreport.com/device/K192907
Methodology: https://510kreport.com/methodology