# K073378: Advance 18LP Pta Dilatation Catheter

- Pathway: 510(k) (Special)
- Applicant: Cook, Inc.
- Decided: Dec 28, 2007 after 25 days
- Product code: DQY (Catheter, Percutaneous)
- 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) PTA Balloon Catheter: named in the summary without a submission number

## Most influential descendants
- K130293: Advance 18LP Low Profile Pta Balloon Dilatation Catheter (2013), 0 descendants of its own

## 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/K073378
Methodology: https://510kreport.com/methodology