# K230705: POT PTCA Balloon Dilatation Catheter

- Pathway: 510(k) (Special)
- Applicant: Brosmed Medical Co., Ltd.
- Decided: Apr 11, 2023 after 28 days
- Product code: LOX (Catheters, Transluminal Coronary Angioplasty, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.5100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to P790017 (1980). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133852: Apollo Balloon Dilatation Catheter, Brosmed Medical (2014) Summary page 5.
- K153742: Apollo Balloon Dilatation Catheter, Brosmed Medical Co., Ltd. (2016) Summary page 5.

## Indications for use
The POT PTCA balloon dilatation catheter is indicated for: ·balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion ·balloon dilatation of a coronary artery occlusion for the treatment of acute myocardial infarction ·balloon dilatation of a stent after implantation (balloon models Ø2.25 mm - Ø5.00 mm only) Note: Bench testing was conducted with the POT PTCA Balloon Dilatation Catheter and marketed balloon expandable stents. Consideration should be taken when this device is used with different manufacturers’ stents due to difference in stent design.

Source page: https://510kreport.com/device/K230705
Methodology: https://510kreport.com/methodology