# K130293: Advance 18LP Low Profile Pta Balloon Dilatation Catheter

- Pathway: 510(k) (Special)
- Applicant: Cook, Inc.
- Decided: May 31, 2013 after 114 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 K073378 (2007). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073378: Advance 18LP Pta Dilatation Catheter, Cook, Inc. (2007) Summary page 1.

## Indications for use
For percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries including iliac, renal, popliteal, infrapopliteal, femoral and iliofemoral as well as obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Source page: https://510kreport.com/device/K130293
Methodology: https://510kreport.com/methodology