# K132020: Advance 34LP Low Profile Pta Balloon Dilatation Catheter

- Pathway: 510(k) (Special)
- Applicant: Cook, Inc.
- Decided: Oct 25, 2013 after 116 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: 1 generation back to K091527 (2009). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
1 of 3 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091527: Advance 35LP Low Profile Pta Balloon Dilatation Catheter, Cook, Inc. (2009) Summary page 1.

## Most influential descendants
- K141322: Advance Enforcer 35 Focal Force Pta Balloon Catheter (2015), 0 descendants of its own

## Indications for use
The Advanceo 35LP Low Profile PTA Balloon Dilatation Catheter has been designed for percutaneous transluniinal angioplasty (PTA) of lesions in peripheral arteries including iliac, renal, popliteal, infrapopliteal, t'emoral and iliofemoral as well as obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Source page: https://510kreport.com/device/K132020
Methodology: https://510kreport.com/methodology