# K141322: Advance Enforcer 35 Focal Force Pta Balloon Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Cook Incorporated
- Decided: Mar 27, 2015 after 311 days
- Product code: PNO (Catheter, Percutaneous, Cutting/Scoring)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: 3 (3 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K091527 (2009). 2 ancestors in all.
No later device cites it as a predicate yet.
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 4.
- K132020: Advance 34LP Low Profile Pta Balloon Dilatation Catheter, Cook, Inc. (2013) Summary page 4.

## Recalls of this device
- May 24, 2019 · Class I · Z-1758-2019: Multiple complaints were received for balloons bursting below the rated burst pressure. Potential adverse events that may occur if an affected product is used include a delay in the procedure, additio
- May 24, 2019 · Class I · Z-1757-2019: Multiple complaints were received for balloons bursting below the rated burst pressure. Potential adverse events that may occur if an affected product is used include a delay in the procedure, additio
- May 24, 2019 · Class I · Z-1756-2019: Multiple complaints were received for balloons bursting below the rated burst pressure. Potential adverse events that may occur if an affected product is used include a delay in the procedure, additio

## Indications for use
The Advance® Enforcer™ 35 Focal Force PTA Balloon 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. Not for use in the cerebral or coronary vasculature.

Source page: https://510kreport.com/device/K141322
Methodology: https://510kreport.com/methodology