# K091527: Advance 35LP Low Profile Pta Balloon Dilatation Catheter

- Pathway: 510(k) (Special)
- Applicant: Cook, Inc.
- Decided: Jun 12, 2009 after 17 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite 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)
- 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
- K132020: Advance 34LP Low Profile Pta Balloon Dilatation Catheter (2013), 1 descendant of its own
- K141322: Advance Enforcer 35 Focal Force Pta Balloon Catheter (2015), 0 descendants of its own

## Recalls of this device
- Apr 16, 2018 · Class II · Z-1521-2018: Incorrect product labeling. Product labeled as 6mm x 2cm balloon are packaged with a 4mm x 4 cm balloon label and vice-versa.

## 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/K091527
Methodology: https://510kreport.com/methodology