# K170193: Advance 14LP Low Profile PTA Balloon Dilatation Catheter

- Pathway: 510(k) (Special)
- Applicant: Cook Incorporated
- Decided: Feb 13, 2017 after 21 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 K090822 (2009). 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)
- K090822: Advance 14RX Rapid Exchange Pta Balloon Catheter, Cook, Inc. (2009) Summary page 4.

## Indications for use
The Advance® 14LP Low Profile PTA Balloon Dilatation Catheter is intended 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/K170193
Methodology: https://510kreport.com/methodology